36 Clinical Development jobs in India
Principal Statistical Programmer FSP - Medical Affairs and Clinical Development
Cytel
Posted 3 days ago
Job Viewed
Job Description
The Principal Statistical Programmer will develop, maintain, validate and run SAS computer programs that access, visualize, analyze, and report clinical trial or registry data in accordance with statistical analysis plans. Ability to work independently and strong SAS/GRAPH programming experience is required. Ability to comprehend complex programming concepts with minimal guidance is also required.
The position reports to the AD or Director of Statistical Programming.
Key Responsibilities:
+ Write SAS programs that produce tables, listings, figures and analysis datasets ;
+ Write SAS programs that validate tables, listings, figures, and analysis datasets;
+ Follow good programming practices, including adequately documenting SAS code;
+ Use, modify, and maintain existing SAS code;
+ Create and maintain file structures for storing clinical data, SAS programs, and statistical output;
+ Assist in developing programming processes consistent with industry best practices;
+ Review DMP, eCRF specs, and other clinical data management documents;
+ Review statistical analysis plans and other related documents;
+ Partner with CRO to perform any of the above tasks;
+ Perform all the tasks with minimal instruction or input from supervisor
+ Review, maintain study documents per standard process
+ Program, test, and document global utility macros and tools in accordance with standards and validation procedures
+ Perform other duties as assigned
Technical and Communication Skills:
+ Proven expert in all SAS language, procedures, and options commonly used in clinical trial reporting including the Macro language, BASE SAS, SAS/STAT and SAS/GRAPH. R shiny experience is a plus
+ Displays highly evolved written and oral presentation skills that enable him/her to disseminate the importance of complex technical solutions more articulately and persuasively
+ Excellent and transparent communication skills and ability to represent the functional group to across stakeholders
Comfortable with quick turnaround and able find an optimum solution for a given problem
Qualifications
+ At least 10 years industry (Pharmaceutical, Biotech, CRO) SAS programming experience or equivalent;
+ Knowledge of clinical trials and experience in using SAS/GRAPH to report the results of clinical trials;
+ Experience in producing and validating SAS programs;
+ Experience in working with CDISC standards, including SDTM, and ADaM;
+ Familiarity with statistical analysis for standard clinical trial outputs;
+ Excellent knowledge of SAS Macro, SAS/SQL, SAS/GRAPH, and SAS/STAT;
+ Good communications skills required;
+ Bachelor's Degree required, Master's Degree Preferred.
+ Clear alignment with the Core Values:
+ Commitment to People
+ Innovation and Discovery
+ Sense of Urgency
+ Open Culture
+ Passion for Excellence
Cytel is a Global CRO providing ground-breaking biostatistical software and services to large pharma and emerging Biotech clients globally. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.
At Cytel, our focus is to provide you with a comprehensive and competitive total reward package. In addition, our world class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
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.
The position reports to the AD or Director of Statistical Programming.
Key Responsibilities:
+ Write SAS programs that produce tables, listings, figures and analysis datasets ;
+ Write SAS programs that validate tables, listings, figures, and analysis datasets;
+ Follow good programming practices, including adequately documenting SAS code;
+ Use, modify, and maintain existing SAS code;
+ Create and maintain file structures for storing clinical data, SAS programs, and statistical output;
+ Assist in developing programming processes consistent with industry best practices;
+ Review DMP, eCRF specs, and other clinical data management documents;
+ Review statistical analysis plans and other related documents;
+ Partner with CRO to perform any of the above tasks;
+ Perform all the tasks with minimal instruction or input from supervisor
+ Review, maintain study documents per standard process
+ Program, test, and document global utility macros and tools in accordance with standards and validation procedures
+ Perform other duties as assigned
Technical and Communication Skills:
+ Proven expert in all SAS language, procedures, and options commonly used in clinical trial reporting including the Macro language, BASE SAS, SAS/STAT and SAS/GRAPH. R shiny experience is a plus
+ Displays highly evolved written and oral presentation skills that enable him/her to disseminate the importance of complex technical solutions more articulately and persuasively
+ Excellent and transparent communication skills and ability to represent the functional group to across stakeholders
Comfortable with quick turnaround and able find an optimum solution for a given problem
Qualifications
+ At least 10 years industry (Pharmaceutical, Biotech, CRO) SAS programming experience or equivalent;
+ Knowledge of clinical trials and experience in using SAS/GRAPH to report the results of clinical trials;
+ Experience in producing and validating SAS programs;
+ Experience in working with CDISC standards, including SDTM, and ADaM;
+ Familiarity with statistical analysis for standard clinical trial outputs;
+ Excellent knowledge of SAS Macro, SAS/SQL, SAS/GRAPH, and SAS/STAT;
+ Good communications skills required;
+ Bachelor's Degree required, Master's Degree Preferred.
+ Clear alignment with the Core Values:
+ Commitment to People
+ Innovation and Discovery
+ Sense of Urgency
+ Open Culture
+ Passion for Excellence
Cytel is a Global CRO providing ground-breaking biostatistical software and services to large pharma and emerging Biotech clients globally. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.
At Cytel, our focus is to provide you with a comprehensive and competitive total reward package. In addition, our world class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
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.
This advertiser has chosen not to accept applicants from your region.
0
Principal Statistical Programmer FSP - Medical Affairs and Clinical Development
Pune, Maharashtra
Cytel
Posted 3 days ago
Job Viewed
Job Description
The Principal Statistical Programmer will develop, maintain, validate and run SAS computer programs that access, visualize, analyze, and report clinical trial or registry data in accordance with statistical analysis plans. Ability to work independently and strong SAS/GRAPH programming experience is required. Ability to comprehend complex programming concepts with minimal guidance is also required.
The position reports to the AD or Director of Statistical Programming.
Key Responsibilities:
+ Write SAS programs that produce tables, listings, figures and analysis datasets ;
+ Write SAS programs that validate tables, listings, figures, and analysis datasets;
+ Follow good programming practices, including adequately documenting SAS code;
+ Use, modify, and maintain existing SAS code;
+ Create and maintain file structures for storing clinical data, SAS programs, and statistical output;
+ Assist in developing programming processes consistent with industry best practices;
+ Review DMP, eCRF specs, and other clinical data management documents;
+ Review statistical analysis plans and other related documents;
+ Partner with CRO to perform any of the above tasks;
+ Perform all the tasks with minimal instruction or input from supervisor
+ Review, maintain study documents per standard process
+ Program, test, and document global utility macros and tools in accordance with standards and validation procedures
+ Perform other duties as assigned
Technical and Communication Skills:
+ Proven expert in all SAS language, procedures, and options commonly used in clinical trial reporting including the Macro language, BASE SAS, SAS/STAT and SAS/GRAPH. R shiny experience is a plus
+ Displays highly evolved written and oral presentation skills that enable him/her to disseminate the importance of complex technical solutions more articulately and persuasively
+ Excellent and transparent communication skills and ability to represent the functional group to across stakeholders
Comfortable with quick turnaround and able find an optimum solution for a given problem
Qualifications
+ At least 10 years industry (Pharmaceutical, Biotech, CRO) SAS programming experience or equivalent;
+ Knowledge of clinical trials and experience in using SAS/GRAPH to report the results of clinical trials;
+ Experience in producing and validating SAS programs;
+ Experience in working with CDISC standards, including SDTM, and ADaM;
+ Familiarity with statistical analysis for standard clinical trial outputs;
+ Excellent knowledge of SAS Macro, SAS/SQL, SAS/GRAPH, and SAS/STAT;
+ Good communications skills required;
+ Bachelor's Degree required, Master's Degree Preferred.
+ Clear alignment with the Core Values:
+ Commitment to People
+ Innovation and Discovery
+ Sense of Urgency
+ Open Culture
+ Passion for Excellence
Cytel is a Global CRO providing ground-breaking biostatistical software and services to large pharma and emerging Biotech clients globally. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.
At Cytel, our focus is to provide you with a comprehensive and competitive total reward package. In addition, our world class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
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.
The position reports to the AD or Director of Statistical Programming.
Key Responsibilities:
+ Write SAS programs that produce tables, listings, figures and analysis datasets ;
+ Write SAS programs that validate tables, listings, figures, and analysis datasets;
+ Follow good programming practices, including adequately documenting SAS code;
+ Use, modify, and maintain existing SAS code;
+ Create and maintain file structures for storing clinical data, SAS programs, and statistical output;
+ Assist in developing programming processes consistent with industry best practices;
+ Review DMP, eCRF specs, and other clinical data management documents;
+ Review statistical analysis plans and other related documents;
+ Partner with CRO to perform any of the above tasks;
+ Perform all the tasks with minimal instruction or input from supervisor
+ Review, maintain study documents per standard process
+ Program, test, and document global utility macros and tools in accordance with standards and validation procedures
+ Perform other duties as assigned
Technical and Communication Skills:
+ Proven expert in all SAS language, procedures, and options commonly used in clinical trial reporting including the Macro language, BASE SAS, SAS/STAT and SAS/GRAPH. R shiny experience is a plus
+ Displays highly evolved written and oral presentation skills that enable him/her to disseminate the importance of complex technical solutions more articulately and persuasively
+ Excellent and transparent communication skills and ability to represent the functional group to across stakeholders
Comfortable with quick turnaround and able find an optimum solution for a given problem
Qualifications
+ At least 10 years industry (Pharmaceutical, Biotech, CRO) SAS programming experience or equivalent;
+ Knowledge of clinical trials and experience in using SAS/GRAPH to report the results of clinical trials;
+ Experience in producing and validating SAS programs;
+ Experience in working with CDISC standards, including SDTM, and ADaM;
+ Familiarity with statistical analysis for standard clinical trial outputs;
+ Excellent knowledge of SAS Macro, SAS/SQL, SAS/GRAPH, and SAS/STAT;
+ Good communications skills required;
+ Bachelor's Degree required, Master's Degree Preferred.
+ Clear alignment with the Core Values:
+ Commitment to People
+ Innovation and Discovery
+ Sense of Urgency
+ Open Culture
+ Passion for Excellence
Cytel is a Global CRO providing ground-breaking biostatistical software and services to large pharma and emerging Biotech clients globally. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.
At Cytel, our focus is to provide you with a comprehensive and competitive total reward package. In addition, our world class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
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.
This advertiser has chosen not to accept applicants from your region.
1
Clinical Data Standards Development Lead
Hyderabad, Andhra Pradesh
beBeeClinicalData
Posted today
Job Viewed
Job Description
Job Opportunity
The Principal Clinical Data Standards Specialist is responsible for the development, maintenance, and implementation of Industry-compliant Clinical Data Standards. They provide expert support to business users and teams on their use in line with the Clinical Data Standards strategy.Key responsibilities include ensuring timely availability of consistent, high-quality Clinical Data Standards deliverables supporting the acquisition and tabulation and/or analysis and reporting of Clinical Trial data across global libraries including;
• Data collection tools in EDC (CRFs, edits checks, derivations, core configurations) and data transfer specifications
• Analysis data/TFL standards
• Associated standard metadata, business rules, and guidelines.
Required Skills and Qualifications
- Expertise in clinical data standards development and maintenance
- Strong analytical and problem-solving skills
- Ability to work collaboratively with cross-functional teams
- Excellent communication and interpersonal skills
Benefits
- Opportunity to work on a high-impact project with a dynamic team
- Professional growth and development opportunities
- Competitive compensation and benefits package
Others
- Collaborative and dynamic work environment
- Flexible work arrangements
- Recognition and rewards for outstanding performance
This advertiser has chosen not to accept applicants from your region.
2
Clinical and Therapy Development Specialist
Delhi, Delhi
Confidential
Posted today
Job Viewed
Job Description
MAIN PURPOSE OF ROLE
Conduct market research and feasibility studies to analyze the viability of alternative business development opportunities.
MAIN RESPONSIBILITIES
Collect, compile, verify, and analyze financial, competitive, sales, marketing, and other information about potential business partners, new markets, products and services, or other business opportunities so that senior management has accurate and timely information for making strategic and operational decisions.
Prepare documents and materials (for example, reports, presentations, information packages) for meetings and negotiations with potential clients and business partners so that the information provided is accurate and appropriate for external distribution.
QUALIFICATIONS
Associates Degree ( 13 years)
No Experience required
Skills Required
Financial Analysis, Sales And Marketing, clinical development
This advertiser has chosen not to accept applicants from your region.
3
Clinical Trials
Ahmedabad, Gujarat
Confidential
Posted today
Job Viewed
Job Description
Description
Education
Post Graduate Diploma in Computer Applications (PGDCA), Master in Computer Application (M.C.A), Master OF Business Administration (M.B.A), Post Graduate Programme in Management for Executives (PGPX), Doctor of Pharmacy (PharmD), Doctor of Veterinary Medicine (DVM), Bachelor of Dental Surgery (B.D.S), Bachelor of Ayurvedic Medicine and Surgery (BAMS), Doctor of Dental Surgery/Medicine (DDS/DMD), Doctor of Nursing Practice (DNP), Bachelor Of Technology (B.Tech/B.E), Master of Library & Information Science (MLIS), Doctor of Public Health (DrPH), Master of Public Administration (MPA), PGDM, Doctor of Psychology (Psy. D./D. Psych.), Bachelor Of Computer Application (B.C.A), Masters in Technology (M.Tech/M.E), Doctor of Physical Therapy, PGP, Bachelors of Law (B.L/L.L.B), Master of Law (M.L/L.L.M), MBBS, Bachelor of Homeopathic Medicine and Surgery (BHMS), Bachelor of Business Administration (B.B.A), Doctor of Optometry, Doctor of Business Administration (DBA), Doctor of Medicine (M.D/M.S)
Skills Required
Clinical Research, Data Analysis, Regulatory Compliance, Project Management, Protocol Development, statistical software, patient recruitment, Risk Management, Quality Assurance, Budget Management
We are seeking an experienced Clinical Trials professional to manage and oversee clinical research studies in India. The ideal candidate will have a strong background in clinical trial design and execution, ensuring compliance with regulatory standards and the safety of trial participants.
Responsibilities- Design and implement clinical trial protocols in compliance with regulatory standards.
- Monitor trial progress and ensure adherence to timelines and budgets.
- Coordinate with various stakeholders, including sponsors, regulatory authorities, and clinical sites.
- Collect, analyze, and interpret data from clinical trials.
- Prepare and submit regulatory documents and reports.
- Train and supervise clinical trial staff and investigators.
- Ensure the safety and well-being of trial participants.
- 6-16 years of experience in clinical trials or related field.
- Strong understanding of Good Clinical Practice (GCP) and regulatory requirements.
- Proficiency in clinical trial management software and electronic data capture systems.
- Excellent organizational and project management skills.
- Strong analytical and problem-solving abilities.
- Effective communication and interpersonal skills.
- Ability to work collaboratively in a team environment.
Education
Post Graduate Diploma in Computer Applications (PGDCA), Master in Computer Application (M.C.A), Master OF Business Administration (M.B.A), Post Graduate Programme in Management for Executives (PGPX), Doctor of Pharmacy (PharmD), Doctor of Veterinary Medicine (DVM), Bachelor of Dental Surgery (B.D.S), Bachelor of Ayurvedic Medicine and Surgery (BAMS), Doctor of Dental Surgery/Medicine (DDS/DMD), Doctor of Nursing Practice (DNP), Bachelor Of Technology (B.Tech/B.E), Master of Library & Information Science (MLIS), Doctor of Public Health (DrPH), Master of Public Administration (MPA), PGDM, Doctor of Psychology (Psy. D./D. Psych.), Bachelor Of Computer Application (B.C.A), Masters in Technology (M.Tech/M.E), Doctor of Physical Therapy, PGP, Bachelors of Law (B.L/L.L.B), Master of Law (M.L/L.L.M), MBBS, Bachelor of Homeopathic Medicine and Surgery (BHMS), Bachelor of Business Administration (B.B.A), Doctor of Optometry, Doctor of Business Administration (DBA), Doctor of Medicine (M.D/M.S)
Skills Required
Clinical Research, Data Analysis, Regulatory Compliance, Project Management, Protocol Development, statistical software, patient recruitment, Risk Management, Quality Assurance, Budget Management
This advertiser has chosen not to accept applicants from your region.
4
Clinical Trials
Pune, Maharashtra
Diabetes Unit KEM Hospital Pune
Posted today
Job Viewed
Job Description
Clinical trials are the actual experimental studies in which human volunteers are included, after their consent, to test new treatments, instruments,
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This advertiser has chosen not to accept applicants from your region.
5
Clinical Trials
Maharashtra, Maharashtra
Diabetes Unit KEM Hospital Pune
Posted today
Job Viewed
Job Description
Clinical trials are the actual experimental studies in which human volunteers are included, after their consent, to test new treatments, instruments,
Read More
Read More
This advertiser has chosen not to accept applicants from your region.
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