4,733 Pharmaceutical jobs in India

**What you will do**
**Supports the product lifecycle through obsolescence by assessing changes made to the device post launch to determine regulatory impact of changes to the current clearance.**
**Ensures regulatory compliance by completing thorough assessments and completing the appropriate submissions pertaining to product clearances/approvals by FDA, Notified Bodies, and other regulatory bodies. Supports new product development for both domestic and international release by contributing to the development and updating of regulatory strategy based upon regulatory changes. Viewed as regulatory team resource.**
**Usually works with minimum supervision having some latitude for independent action or decision, conferring with more senior and supervisory staff when indicated, and keeps supervisor regularly informed on status of work.**
**Developing and applying basic knowledge and understanding of the regulatory and legal frameworks, regulatory requirements, legislation, processes and procedures.**
**Project management, writing, coordination, and execution of regulatory items; Completing technical and scientific regulatory assignments that are broad in nature.**
**Assisting in SOP development and review; Assisting in the development and update of regulatory strategy based upon regulatory changes.**
**Providing regulatory input new product development and product lifecycle planning; Evaluating regulatory impact of proposed changes to launched products.**
**Demonstrating understanding and ability to investigate and evaluate regulatory history/background of class, disease/therapeutic/diagnostic context in the assessment of regulatory implications.**
**Determining and communicating submission and approval requirements.**
**What you need:**
**Required-**
**Bachelor's or Master's degree in Regulatory Affairs, Engineering or equivalent discipline is required.**
**3 - 5 years experience in an equivalent position within an R&D environment is preferred**
**Preferred-**
**Experience with post-market and change management is a distinct advantage**
**RAC Certification is preferred**
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.
Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer - M/F/Veteran/Disability.

Individuals in Quality Assurance, Monitoring & Testing are responsible for the assessment of outcomes from activities and processes against conformance with applicable requirements to strengthen risk management quality such as quality testing performed for business function quality control and transformation lead quality control post completion of an activity/process. This includes the development and execution of Monitoring and Testing for controls, such as control design assessment, design of operational effectiveness for monitoring & testing tools, monitoring/testing design assessment, and execution of monitoring/testing tools to assess the effectiveness of key controls designed to address defined risks.
**Responsibilities** :
+ Good understanding of the Citi Risk & control framework and the underlying fundamentals on Risk Management
+ Support in performing the monitoring review that augment the principles defined per ARCM (Activity, Risk, Control & Monitoring)
+ Support in the end-to-end monitoring of the controls as defined in Risk Management policy
+ Participate in strategic initiatives for control performance enhancement, etc.
+ Involve in Control & Monitoring Design Assessment (CMDA) meetings and provide help in drafting the procedures.
+ Participate in leadership meetings to analyze documentation and processes to ensure risks and control points are properly addressed
+ Help to identify any monitoring breaks and suggest enhancements
+ Assisting in the creation and maintenance of reports for control tracking and analysis
+ Help to identify risks across the business and organize cross-functional solutions
+ Appropriately assess risk when business decisions are made, demonstrating particular consideration for the firm's reputation and safeguarding Citigroup, its clients and assets, by driving compliance with applicable laws, rules and regulations, adhering to Policy, applying sound ethical judgment regarding personal behavior, conduct and business practices, and escalating, managing and reporting control issues with transparency, as well as effectively supervise the activity of teams and create accountability with those who fail to maintain these standards
**Qualifications** :
+ Minimum of 2-5 years of experience in operational risk management, compliance, audit, or other control-related functions in the financial services industry.
+ Ability to identify, measure, and manage key risks and controls.
+ Good knowledge in the development and execution for controls.
+ Experience in control related functions in the financial industry.
+ Experience in implementing sustainable solutions and improving processes.
+ Understanding of compliance laws, rules, regulations, and best practices.
+ Understanding of Citi's Policies, Standards, and Procedures.
+ Good analytical skills to evaluate complex risk and control activities and processes.
+ Excellent verbal and written communication skills, with a demonstrated ability to engage at the senior management level.
+ Problem-solving and decision-making skills.
+ Ability to manage multiple tasks and priorities.
+ Proficiency in Microsoft Office suite, particularly Excel, PowerPoint, and Word.
**Education** :
Bachelor's/University degree or equivalent experience
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**Job Family Group:**
Controls Governance & Oversight
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**Job Family:**
Quality Assurance, Monitoring & Testing
---
**Time Type:**
Full time
---
**Most Relevant Skills**
Analytical Thinking, Assurance Strategy, Communication, Constructive Debate, Controls Assessment, Controls Lifecycle, Policy and Procedure, Risk Remediation, Stakeholder Management.
---
**Other Relevant Skills**
For complementary skills, please see above and/or contact the recruiter.
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_Citi is an equal opportunity employer, and qualified candidates will receive consideration without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other characteristic protected by law._
_If you are a person with a disability and need a reasonable accommodation to use our search tools and/or apply for a career opportunity review_ _Accessibility at Citi ( _._
_View Citi's_ _EEO Policy Statement ( _and the_ _Know Your Rights ( _poster._
Citi is an equal opportunity and affirmative action employer.
Minority/Female/Veteran/Individuals with Disabilities/Sexual Orientation/Gender Identity.

The Central Control Capabilities function is responsible for driving Monitoring & Testing (M&T) of key controls across the enterprise. It comprises of four groups: (1) Control Assessment, (2) Call Listening, **(3) Central Testing** , and (4) Strategy, Governance & Automation (SG&A).
This role is part of the Central Testing team. The Control Assessment and Central Testing functions partner with the Control Owners and the In-business Control Teams to conduct all the M&T activities for the key controls in scope.
The Central Testing function is primarily based out of Citi Service Centers in India. It is structured along three verticals: (1) M&T Execution, (2) M&T Automation, and (3) Strategy & Governance. The identified candidate for this role will be part of the M&T Execution team.
**Responsibilities:**
+ Have a good understanding of the Risk & control framework and the underlying concepts on Risk Management
+ Assist in performing the Quality check on the monitoring reviews that are defined per ARCM (Activity, Risk, Control & Monitoring)
+ Document the quality fails, any learnings or issues that may arise and pass the feedback to the Supervisor
+ Monitor the compliance of control as appropriate to the regulatory requirement. This could be mostly in the Medium to High complex reviews with an Inherent Risk rating of 1 or 2 (predominantly)
+ Provide inputs during the Control & Monitoring Design Assessment (CMDA) to draft and define the procedures
+ Involved in the assessment of the timeliness, accuracy and completeness of the MCA (Manager Control Assessment) through controls
+ Coordinate the adherence to the MCA Standard through controls after the execution of a process
+ Collaborating with onshore and offshore teams understanding the process changes if any and participate in trainings, meetings & etc. Escalate any control failures
+ Complete the quality check within a timely manner to complement the results submission timeline in the Risk & Control system
+ Assisting in the creation and maintenance of reports for control tracking and analysis
+ Identify risks across the business and organize cross-functional solutions
+ Challenge the status quo of existing controls & identify opportunities for enhancement
+ Additional duties as assigned
**Qualifications:**
+ 5+ to 7 years of relevant work experience in Risk & Control domain viz. internal control/ quality check/ monitoring is required
+ Past experience in control/ monitoring design would be an added preference but not essential
+ Demonstrated analytical skills with follow-up and problem-solving capability
+ Excellent written and verbal communication skills
+ Ability to perform under pressure
+ Ability to manage multiple tasks and priorities Ability to function independently
+ Proficient in MS Office Word, Excel and PowerPoint applications
**Education:**
+ Bachelor's/University degree
---
**Job Family Group:**
Controls Governance & Oversight
---
**Job Family:**
Quality Assurance, Monitoring & Testing
---
**Time Type:**
Full time
---
**Most Relevant Skills**
Analytical Thinking, Assurance Strategy, Communication, Constructive Debate, Controls Assessment, Controls Lifecycle, Policy and Procedure, Risk Remediation, Stakeholder Management.
---
**Other Relevant Skills**
For complementary skills, please see above and/or contact the recruiter.
---
_Citi is an equal opportunity employer, and qualified candidates will receive consideration without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other characteristic protected by law._
_If you are a person with a disability and need a reasonable accommodation to use our search tools and/or apply for a career opportunity review_ _Accessibility at Citi ( _._
_View Citi's_ _EEO Policy Statement ( _and the_ _Know Your Rights ( _poster._
Citi is an equal opportunity and affirmative action employer.
Minority/Female/Veteran/Individuals with Disabilities/Sexual Orientation/Gender Identity.

**The Position**
Will be responsible for executing medical affairs strategy in the assigned zone.
**Tasks & responsibilities**
+ Understand the current practices, medicines being used, and trends in relation to their respective therapeutic area through key customer contacts, attending scientific symposia and reviewing key therapeutic journals in order to provide relevant information to internal and external customers.
+ Effectively gathers and disseminates information in a concise and understandable format to both internal and external customers and position BI Medical as a preferred partner for key customers through credible and clear non-promotional communication Execute key medical projects (e.g. IIS studies) to ensure that BI interacts most efficiently with customers and key customer networks through optimal contact, so as to bring significant value to both the customer and BI
+ Participate in the implementation of the local medico marketing strategy.
+ Identify the EEs in the territory. Develop relationship with team and network for effective promotion of BI and BI products. Give feedback to the management regularly about KOL development.
+ Provide medical and product expertise towards registration of new products/indications with federal/state regulatory authorities through delivery of scientific presentations, provision of medical rationale and published literature, and liaison with key HCPs for obtaining support for new product/indication.
+ Provide medical and product expertise towards defense of marketed products (regulators, NGOs, press, etc.)
+ Write, revise, and review labeling documents for pipeline/local products per relevant SOPs.
+ Assist regulatory affairs with EE access when appropriate.
**Requirements**
+ Education : Medical degree (preferable qualification in Pharmacology), or qualification in life-sciences.
+ Preferably 0-3 years experience on the same field and Pharmaceutical or Healthcare industry. Beginner level can apply as long as candidate is graduate of MD of Pharmacology. For professional without doctoral qualification, relevant field-based work experience of 10+ years with good scientific expertise is preferable.
+ Scientific expertise on diabetes therapy area is required.
+ Excellent interpersonal skill.
+ Basic IT Knowledge on MS Office applications
+ Role is based in Kolkata / Hyderabad
**READY TO APPLY?**
Click the _"Apply On Company website"_ button. Create an account or sign in and continue to register your profile, upload your resume, and apply in the company site.
For any technical issues or additional questions, contact HR Direct. (Note: resumes should not be submitted to HR Direct since job applications are not processed via email or phone call)
HR Direct contact information:
Phone:
Email:
All qualified applicants will receive consideration for employment without regard to a person's actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.

**The Position**
Will be responsible for executing medical affairs strategy in the assigned zone.
**Tasks & responsibilities**
+ Understand the current practices, medicines being used, and trends in relation to their respective therapeutic area through key customer contacts, attending scientific symposia and reviewing key therapeutic journals in order to provide relevant information to internal and external customers.
+ Effectively gathers and disseminates information in a concise and understandable format to both internal and external customers and position BI Medical as a preferred partner for key customers through credible and clear non-promotional communication Execute key medical projects (e.g. IIS studies) to ensure that BI interacts most efficiently with customers and key customer networks through optimal contact, so as to bring significant value to both the customer and BI
+ Participate in the implementation of the local medico marketing strategy.
+ Identify the EEs in the territory. Develop relationship with team and network for effective promotion of BI and BI products. Give feedback to the management regularly about KOL development.
+ Provide medical and product expertise towards registration of new products/indications with federal/state regulatory authorities through delivery of scientific presentations, provision of medical rationale and published literature, and liaison with key HCPs for obtaining support for new product/indication.
+ Provide medical and product expertise towards defense of marketed products (regulators, NGOs, press, etc.)
+ Write, revise, and review labeling documents for pipeline/local products per relevant SOPs.
+ Assist regulatory affairs with EE access when appropriate.
**Requirements**
+ Education : Medical degree (preferable qualification in Pharmacology), or qualification in life-sciences.
+ Preferably 0-3 years experience on the same field and Pharmaceutical or Healthcare industry. Beginner level can apply as long as candidate is graduate of MD of Pharmacology. For professional without doctoral qualification, relevant field-based work experience of 10+ years with good scientific expertise is preferable.
+ Scientific expertise on diabetes therapy area is required.
+ Excellent interpersonal skill.
+ Basic IT Knowledge on MS Office applications
+ Role is based in Kolkata / Hyderabad
**READY TO APPLY?**
Click the _"Apply On Company website"_ button. Create an account or sign in and continue to register your profile, upload your resume, and apply in the company site.
For any technical issues or additional questions, contact HR Direct. (Note: resumes should not be submitted to HR Direct since job applications are not processed via email or phone call)
HR Direct contact information:
Phone:
Email:
All qualified applicants will receive consideration for employment without regard to a person's actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.

**The Position**
Will be responsible for executing medical affairs strategy in the assigned zone.
**Tasks & responsibilities**
+ Understand the current practices, medicines being used, and trends in relation to their respective therapeutic area through key customer contacts, attending scientific symposia and reviewing key therapeutic journals in order to provide relevant information to internal and external customers.
+ Effectively gathers and disseminates information in a concise and understandable format to both internal and external customers and position BI Medical as a preferred partner for key customers through credible and clear non-promotional communication Execute key medical projects (e.g. IIS studies) to ensure that BI interacts most efficiently with customers and key customer networks through optimal contact, so as to bring significant value to both the customer and BI
+ Participate in the implementation of the local medico marketing strategy.
+ Identify the EEs in the territory. Develop relationship with team and network for effective promotion of BI and BI products. Give feedback to the management regularly about KOL development.
+ Provide medical and product expertise towards registration of new products/indications with federal/state regulatory authorities through delivery of scientific presentations, provision of medical rationale and published literature, and liaison with key HCPs for obtaining support for new product/indication.
+ Provide medical and product expertise towards defense of marketed products (regulators, NGOs, press, etc.)
+ Write, revise, and review labeling documents for pipeline/local products per relevant SOPs.
+ Assist regulatory affairs with EE access when appropriate.
**Requirements**
+ Education : Medical degree (preferable qualification in Pharmacology), or qualification in life-sciences.
+ Preferably 0-3 years experience on the same field and Pharmaceutical or Healthcare industry. Beginner level can apply as long as candidate is graduate of MD of Pharmacology. For professional without doctoral qualification, relevant field-based work experience of 10+ years with good scientific expertise is preferable.
+ Scientific expertise on diabetes therapy area is required.
+ Excellent interpersonal skill.
+ Basic IT Knowledge on MS Office applications
+ Role is based in Delhi
**READY TO APPLY?**
Click the _"Apply On Company website"_ button. Create an account or sign in and continue to register your profile, upload your resume, and apply in the company site.
For any technical issues or additional questions, contact HR Direct. (Note: resumes should not be submitted to HR Direct since job applications are not processed via email or phone call)
HR Direct contact information:
Phone:
Email:
All qualified applicants will receive consideration for employment without regard to a person's actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
**A Day in the Life**
Responsibilities may include the following and other duties may be assigned.
+ Clinical
+ Collects, maintains, archives, and retrieves necessary source documents to ensure compliance with applicable SOPs and complete Scientific communication deliverables
+ Supports leadership in compiling necessary documents and other tasks during audits
+ Supports submission related activities which may include but not limited to CAP Agile upload and Veeva review/upload
+ Assist in the development and execution of meetings between internal and external cross-functional partners
+ Develops mechanisms for monitoring project progress and for intervention and problem-solving with leadership.
+ Assists in tracking and reporting on metrics related to medical writing and information deliverables services to leadership
+ Regulatory Technical Communications
+ Creates, reviews, and reproduces text required for labeling medical products.
+ Ensures that labeling, art, film, and plate proofs meet all medical, legal, and regulatory requirements.
+ Monitors changes in labeling regulations in the US and/or abroad.
+ Reviews promotional and commercial communication material and ensures that it is supported by the data and consistent with the application.
+ Monitor, evaluate and recommend improvements to labeling processes, quality, systems tools, and/or policies.
**SPECIALIST CAREER STREAM:** An individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. Most of the time is spent delivering and overseeing the projects while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education.
**DIFFERENTIATING FACTORS**
**Autonomy:** Entry-level individual contributor on a project or work team. Works with close supervision.
**Organizational Impact:** Delivers work of limited scope, typically smaller, less complex projects, or related activities.
**Innovation and Complexity:** Identifies, defines, and addresses problems that are not immediately evident but typically not difficult or complex.
Makes minor changes in systems and processes to solve problems.
**Communication and Influence:** Communicates primarily with internal contacts within immediate group.
Contacts others to gather, confirm and convey information.
**Leadership and Talent Management:** N / A - job at this level is focused on self-development.
**Required Knowledge and Experience:** Requires broad theoretical job knowledge typically obtained through advanced education.
Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A), 2-4 years of experience required.
**Physical Job Requirements**
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. 
**Benefits & Compensation**
**Medtronic offers a competitive Salary and flexible Benefits Package**
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
**About Medtronic**
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
Learn more about our business, mission, and our commitment to diversity here ( lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
**We change lives** . Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That's who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives.
**We build extraordinary solutions as one team** . With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough.
**This life-changing career is yours to engineer** . By bringing your ambitious ideas, unique perspective and contributions, you will.
+ **Build** a better future, amplifying your impact on the causes that matter to you and the world
+ **Grow** a career reflective of your passion and abilities
+ **Connect** to a dynamic and inclusive culture that welcomes the challenge of life-long learning
These commitments set our team apart from the rest:
**Experiences that put people first** . Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need.
**Life-transforming technologies** . No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms.
**Better outcomes for our world** . Here, it's about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls.
**Insight-driven care** . Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support.
This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here ( .
For updates on job applications, please go to the candidate login page and sign in to check your application status.
If you need assistance completing your application please email
To request removal of your personal information from our systems please email

**Sponsor-dedicated:**
Working fully embedded within one of our pharmaceutical clients, with the support of Cytel right behind you, you'll be at the heart of our client's innovation. As a Senior Statistical Programmer you will be dedicated to one of our global pharmaceutical clients; a company that is driving the next generation of patient treatment, where individuals are empowered to work with autonomy and ownership. This is an exciting time to be a part of this new program.
**Position Overview:**
As a Senior Statistical Programmer, you will leverage your advanced SAS programming skills and proficiency in CDISC standards (SDTM & ADaM) to support or lead one or more Phase I-IV clinical trials. This role can be performed as fully remote.
**Our values**
+ We believe in applying scientific rigor to reveal the full promise inherent in data.
+ We nurture intellectual curiosity and encourage everyone to approach new challenges with enthusiasm and the desire for discovery.
+ We believe in collaboration and invite a diversity of perspectives, drawing on a variety of talents to create a wealth of possibilities.
+ We prize innovation and seek intelligent solutions using leading-edge technology.
**How you will contribute:**
+ Performing data manipulation, analysis and reporting of clinical trial data, both safety and efficacy (ISS/ISE), utilizing SAS programming
+ Generating and validating SDTM and ADaM datasets/analysis files, and tables, listings, and figures (TLFs)
+ Production and QC / validation programming
+ Generating complex ad-hoc reports utilizing raw data
+ Applying strong understanding/experience of Efficacy analysis
+ Creating and reviewing submission documents and eCRTs
+ Communicating with and/or responding to internal cross-functional teams and client for project specifications, status, issues or inquiries
+ Performing lead duties when called upon
+ Serving as team player, with a willingness to go the extra distance to get results, meet deadlines, etc.
+ Being adaptable and flexible when priorities change
**Here at Cytel we want our employees to succeed and we enable this success through consistent training, development and support. To be successful in this position you will have:**
+ Bachelor's degree in one of the following fields Statistics, Computer Science, Mathematics, etc.
+ At least 8 years of SAS programming working with clinical trial data in the Pharmaceutical & Biotech industry with a bachelor's degree or equivalent. At least 6 years of related experience with a master's degree or above.
+ Study lead experience, preferably juggling multiple projects simultaneously preferred.
+ Strong SAS data manipulation, analysis and reporting skills.
+ Solid experience implementing the latest CDISC SDTM / ADaM standards.
+ Strong QC / validation skills.
+ Good ad-hoc reporting skills.
+ Proficiency in Efficacy analysis.
+ Familiarity with drug development life cycle and experience with the manipulation, analysis and reporting of clinical trials' data.
+ Submissions experience utilizing define.xml and other submission documents.
+ Experience supporting immunology, respiratory or oncology studies would be a plus.
+ Excellent analytical & troubleshooting skills.
+ Ability to provide quality output and deliverables, in adherence with challenging timelines.
+ Ability to work effectively and successfully in a globally dispersed team environment with cross-cultural partners.
Cytel Inc. is an Equal Employment / Affirmative Action Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law.

**Sponsor-dedicated:**
Working fully embedded within one of our pharmaceutical clients, with the support of Cytel right behind you, you'll be at the heart of our client's innovation. As a Senior Statistical Programmer you will be dedicated to one of our global pharmaceutical clients; a company that is driving the next generation of patient treatment, where individuals are empowered to work with autonomy and ownership. This is an exciting time to be a part of this new program.
**Position Overview:**
As a Senior Statistical Programmer, you will leverage your advanced SAS programming skills and proficiency in CDISC standards (SDTM & ADaM) to support or lead one or more Phase I-IV clinical trials. This role can be performed as fully remote.
**Our values**
+ We believe in applying scientific rigor to reveal the full promise inherent in data.
+ We nurture intellectual curiosity and encourage everyone to approach new challenges with enthusiasm and the desire for discovery.
+ We believe in collaboration and invite a diversity of perspectives, drawing on a variety of talents to create a wealth of possibilities.
+ We prize innovation and seek intelligent solutions using leading-edge technology.
**How you will contribute:**
+ Performing data manipulation, analysis and reporting of clinical trial data, both safety and efficacy (ISS/ISE), utilizing SAS programming
+ Generating and validating SDTM and ADaM datasets/analysis files, and tables, listings, and figures (TLFs)
+ Production and QC / validation programming
+ Generating complex ad-hoc reports utilizing raw data
+ Applying strong understanding/experience of Efficacy analysis
+ Creating and reviewing submission documents and eCRTs
+ Communicating with and/or responding to internal cross-functional teams and client for project specifications, status, issues or inquiries
+ Performing lead duties when called upon
+ Serving as team player, with a willingness to go the extra distance to get results, meet deadlines, etc.
+ Being adaptable and flexible when priorities change
**Here at Cytel we want our employees to succeed and we enable this success through consistent training, development and support. To be successful in this position you will have:**
+ Bachelor's degree in one of the following fields Statistics, Computer Science, Mathematics, etc.
+ At least 8 years of SAS programming working with clinical trial data in the Pharmaceutical & Biotech industry with a bachelor's degree or equivalent. At least 6 years of related experience with a master's degree or above.
+ Study lead experience, preferably juggling multiple projects simultaneously preferred.
+ Strong SAS data manipulation, analysis and reporting skills.
+ Solid experience implementing the latest CDISC SDTM / ADaM standards.
+ Strong QC / validation skills.
+ Good ad-hoc reporting skills.
+ Proficiency in Efficacy analysis.
+ Familiarity with drug development life cycle and experience with the manipulation, analysis and reporting of clinical trials' data.
+ Submissions experience utilizing define.xml and other submission documents.
+ Experience supporting immunology, respiratory or oncology studies would be a plus.
+ Excellent analytical & troubleshooting skills.
+ Ability to provide quality output and deliverables, in adherence with challenging timelines.
+ Ability to work effectively and successfully in a globally dispersed team environment with cross-cultural partners.
Cytel Inc. is an Equal Employment / Affirmative Action Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law.