19,482 Lead Programmer jobs in India

SAS Clinical lead programmer

Chennai, Tamil Nadu Anicalls (Pty) Ltd

Posted today

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Job Description

• Minimum 5 years of experience with SAS programming for clinical trial data.
• Generate data sets, tables, listings, and figure outputs
• Establish standardized programming procedures and work instructions. Technical Requirements for SAS Programmer
• Work directly with the ClientClient to establish timelines and assign tasks.
• Strong background working in a CRO or Pharmaceutical environment.
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LEAD STATISTICAL PROGRAMMER

Bengaluru, Karnataka ACL Digital

Posted 4 days ago

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Job Description

LEAD STATISTICAL PROGRAMMER (9 – 11 YEARS)


LOCATION: ANYWHERE IN INDIA


WORK MODE - HYBRID


ROLES and RESPONSIBILITIES:

  • Perform review of Protocol, Case Report Forms, annotated Case Report Forms, Statistical Analysis Plan, and mock shell
  • Review Specifications, SDTM domains, ADaM datasets, TLFs, P21 reports, define packages (Define.xml), and Reviewers guide (RGs) for all the deliverables
  • Develop and/or validate SDTM domains, ADaM datasets, and TLFs using SAP and mock shells
  • Setup the folder structure for the assigned study as per the SOP
  • Forecast the work for the team and provide a vision of the ongoing project objectives/milestones and provide clarity on the upcoming projects
  • Provide the study status to the Project Manager/Client periodically
  • Identify, communicate, and manage study-based risks and issues within the timeframe to the Project manager/Clients
  • Maintain supporting documentation for studies in accordance with SOPs, and Work Instructions (WI) to ensure traceability and regulatory compliance
  • Contribute to the development of Statistical Programming standards and processes to improve the quality, productivity, and efficiency
  • Adhere to learning and developing knowledge on the latest in CDISC Therapeutic standards, GCP, and applicable ICH guidelines
  • Provide guidance, mentoring, and training for junior team members as appropriate.
  • Ensure audit readiness and quality control for all assigned statistical programming
  • deliverables as well as the accuracy and reliability of statistical analysis results
  • To ensure that the assigned team members are in compliance with SOPs and training requirements
This advertiser has chosen not to accept applicants from your region.

LEAD STATISTICAL PROGRAMMER

Bengaluru, Karnataka ACL Digital

Posted today

Job Viewed

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Job Description

LEAD STATISTICAL PROGRAMMER (9 – 11 YEARS)

LOCATION: ANYWHERE IN INDIA

WORK MODE - HYBRID

ROLES and RESPONSIBILITIES:

  • Perform review of Protocol, Case Report Forms, annotated Case Report Forms, Statistical Analysis Plan, and mock shell
  • Review Specifications, SDTM domains, ADaM datasets, TLFs, P21 reports, define packages (Define.xml), and Reviewers guide (RGs) for all the deliverables
  • Develop and/or validate SDTM domains, ADaM datasets, and TLFs using SAP and mock shells
  • Setup the folder structure for the assigned study as per the SOP
  • Forecast the work for the team and provide a vision of the ongoing project objectives/milestones and provide clarity on the upcoming projects
  • Provide the study status to the Project Manager/Client periodically
  • Identify, communicate, and manage study-based risks and issues within the timeframe to the Project manager/Clients
  • Maintain supporting documentation for studies in accordance with SOPs, and Work Instructions (WI) to ensure traceability and regulatory compliance
  • Contribute to the development of Statistical Programming standards and processes to improve the quality, productivity, and efficiency
  • Adhere to learning and developing knowledge on the latest in CDISC Therapeutic standards, GCP, and applicable ICH guidelines
  • Provide guidance, mentoring, and training for junior team members as appropriate.
  • Ensure audit readiness and quality control for all assigned statistical programming
  • deliverables as well as the accuracy and reliability of statistical analysis results
  • To ensure that the assigned team members are in compliance with SOPs and training requirements
This advertiser has chosen not to accept applicants from your region.

Lead statistical programmer

Bengaluru, Karnataka ACL Digital

Posted today

Job Viewed

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Job Description

LEAD STATISTICAL PROGRAMMER (9 – 11 YEARS)LOCATION: ANYWHERE IN INDIAWORK MODE - HYBRIDROLES and RESPONSIBILITIES: Perform review of Protocol, Case Report Forms, annotated Case Report Forms, Statistical Analysis Plan, and mock shellReview Specifications, SDTM domains, ADa M datasets, TLFs, P21 reports, define packages (Define.xml), and Reviewers guide (RGs) for all the deliverables Develop and/or validate SDTM domains, ADa M datasets, and TLFs using SAP and mock shellsSetup the folder structure for the assigned study as per the SOPForecast the work for the team and provide a vision of the ongoing project objectives/milestones and provide clarity on the upcoming projectsProvide the study status to the Project Manager/Client periodicallyIdentify, communicate, and manage study-based risks and issues within the timeframe to the Project manager/ClientsMaintain supporting documentation for studies in accordance with SOPs, and Work Instructions (WI) to ensure traceability and regulatory complianceContribute to the development of Statistical Programming standards and processes to improve the quality, productivity, and efficiencyAdhere to learning and developing knowledge on the latest in CDISC Therapeutic standards, GCP, and applicable ICH guidelinesProvide guidance, mentoring, and training for junior team members as appropriate.Ensure audit readiness and quality control for all assigned statistical programming deliverables as well as the accuracy and reliability of statistical analysis resultsTo ensure that the assigned team members are in compliance with SOPs and training requirements

This advertiser has chosen not to accept applicants from your region.

LEAD STATISTICAL PROGRAMMER

Bengaluru, Karnataka ACL Digital

Posted 4 days ago

Job Viewed

Tap Again To Close

Job Description

LEAD STATISTICAL PROGRAMMER (9 – 11 YEARS)

LOCATION: ANYWHERE IN INDIA

WORK MODE - HYBRID

ROLES and RESPONSIBILITIES:
Perform review of Protocol, Case Report Forms, annotated Case Report Forms, Statistical Analysis Plan, and mock shell
Review Specifications, SDTM domains, ADaM datasets, TLFs, P21 reports, define packages (Define.xml), and Reviewers guide (RGs) for all the deliverables
Develop and/or validate SDTM domains, ADaM datasets, and TLFs using SAP and mock shells
Setup the folder structure for the assigned study as per the SOP
Forecast the work for the team and provide a vision of the ongoing project objectives/milestones and provide clarity on the upcoming projects
Provide the study status to the Project Manager/Client periodically
Identify, communicate, and manage study-based risks and issues within the timeframe to the Project manager/Clients
Maintain supporting documentation for studies in accordance with SOPs, and Work Instructions (WI) to ensure traceability and regulatory compliance
Contribute to the development of Statistical Programming standards and processes to improve the quality, productivity, and efficiency
Adhere to learning and developing knowledge on the latest in CDISC Therapeutic standards, GCP, and applicable ICH guidelines
Provide guidance, mentoring, and training for junior team members as appropriate.
Ensure audit readiness and quality control for all assigned statistical programming
deliverables as well as the accuracy and reliability of statistical analysis results
To ensure that the assigned team members are in compliance with SOPs and training requirements
This advertiser has chosen not to accept applicants from your region.

LEAD STATISTICAL PROGRAMMER

Bengaluru, Karnataka ACL Digital

Posted today

Job Viewed

Tap Again To Close

Job Description

LEAD STATISTICAL PROGRAMMER (9 – 11 YEARS)


LOCATION: ANYWHERE IN INDIA


WORK MODE - HYBRID


ROLES and RESPONSIBILITIES:

  • Perform review of Protocol, Case Report Forms, annotated Case Report Forms, Statistical Analysis Plan, and mock shell
  • Review Specifications, SDTM domains, ADaM datasets, TLFs, P21 reports, define packages (Define.xml), and Reviewers guide (RGs) for all the deliverables
  • Develop and/or validate SDTM domains, ADaM datasets, and TLFs using SAP and mock shells
  • Setup the folder structure for the assigned study as per the SOP
  • Forecast the work for the team and provide a vision of the ongoing project objectives/milestones and provide clarity on the upcoming projects
  • Provide the study status to the Project Manager/Client periodically
  • Identify, communicate, and manage study-based risks and issues within the timeframe to the Project manager/Clients
  • Maintain supporting documentation for studies in accordance with SOPs, and Work Instructions (WI) to ensure traceability and regulatory compliance
  • Contribute to the development of Statistical Programming standards and processes to improve the quality, productivity, and efficiency
  • Adhere to learning and developing knowledge on the latest in CDISC Therapeutic standards, GCP, and applicable ICH guidelines
  • Provide guidance, mentoring, and training for junior team members as appropriate.
  • Ensure audit readiness and quality control for all assigned statistical programming
  • deliverables as well as the accuracy and reliability of statistical analysis results
  • To ensure that the assigned team members are in compliance with SOPs and training requirements
This advertiser has chosen not to accept applicants from your region.

LEAD STATISTICAL PROGRAMMER

Bangalore, Karnataka ACL Digital

Posted 1 day ago

Job Viewed

Tap Again To Close

Job Description

LEAD STATISTICAL PROGRAMMER (9 – 11 YEARS)


LOCATION: ANYWHERE IN INDIA


WORK MODE - HYBRID


ROLES and RESPONSIBILITIES:

  • Perform review of Protocol, Case Report Forms, annotated Case Report Forms, Statistical Analysis Plan, and mock shell
  • Review Specifications, SDTM domains, ADaM datasets, TLFs, P21 reports, define packages (Define.xml), and Reviewers guide (RGs) for all the deliverables
  • Develop and/or validate SDTM domains, ADaM datasets, and TLFs using SAP and mock shells
  • Setup the folder structure for the assigned study as per the SOP
  • Forecast the work for the team and provide a vision of the ongoing project objectives/milestones and provide clarity on the upcoming projects
  • Provide the study status to the Project Manager/Client periodically
  • Identify, communicate, and manage study-based risks and issues within the timeframe to the Project manager/Clients
  • Maintain supporting documentation for studies in accordance with SOPs, and Work Instructions (WI) to ensure traceability and regulatory compliance
  • Contribute to the development of Statistical Programming standards and processes to improve the quality, productivity, and efficiency
  • Adhere to learning and developing knowledge on the latest in CDISC Therapeutic standards, GCP, and applicable ICH guidelines
  • Provide guidance, mentoring, and training for junior team members as appropriate.
  • Ensure audit readiness and quality control for all assigned statistical programming
  • deliverables as well as the accuracy and reliability of statistical analysis results
  • To ensure that the assigned team members are in compliance with SOPs and training requirements
This advertiser has chosen not to accept applicants from your region.
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Team Lead Statistical Programmer

Hyderabad, Andhra Pradesh Sanofi Group

Posted 3 days ago

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Job Description

**About the job**
**Our Team:**
Sanofi Global Hub is an internal Sanofi resource organization based in India and is setup to centralize processes and activities to support Specialty Care, Vaccines, General Medicines, CHC, CMO, and R&D, Data & Digital functions. Sanofi Global Hub strives to be a strategic and functional partner for tactical deliveries to Medical, HEVA, and Commercial organizations in Sanofi, globally.
**Main responsibilities:**
The Team Lead Statistical Programmer will work with Medical Affairs biostatisticians and Sanofi Global Hub biostatistics and programming personnel to implement statistical analysis plans and provide QC'd data packages including tables, figures, and listings for use in publications (i.e., abstracts, posters, oral, presentations, and manuscripts); The Team Lead Statistical Programmer Provides leadership, guidance, and strategic inputs for all Sanofi Global Hub Programming personnel with different level of expertise through all projects of one or more TAs, and ensure their team members are current with advanced statistical programming techniques; The Team Lead Statistical Programmer will develop, implement, and document non-routine macros and advanced techniques; The Team Lead Statistical Programmer will ensure SOPs are followed and timelines and quality metrics are met; Secure delivery of high-quality of deliverables (TLFs) in time and in compliance with internal and external standards; Manage and ensure stakeholder's expectations - ramping up programming teams and day to day operations to meet business requirements.
**People:**
1) Develop and maintain effective relationships and collaborations with the end stakeholders (Medical community) and local biostatistics and programming team members within the allocated Global business unit and product - with an objective to develop statistical data outputs.
2) Actively support to maintain interface between Medical Activities Hub and Stakeholder by facilitating regular interaction and implementing appropriate trackers.
3)Ensure continuous assistance to new team members to support efficient and quick onboarding and knowledge sharing sessions across Sanofi Global Hub.
**Performance / Process:**
1) Conduct appropriate post-hoc statistical analyses of clinical trial data.
2) Lead/contribute to the global coordination efforts to identify, develop, innovate/automate and implement departmental standards, applications, processes and trainings; participate to the evaluation of tools/applications and endorse their development.
3) Collaborate effectively with Principal biostatisticians and programmers to ensure high quality and timely statistical programming deliverables across the TAs.
4) Design, develop, test, implement, and document statistical programming in high-level software packages e.g., SAS.
5) Produce well documented data packages that include tables, listings, and figures.
6) Work closely with the Head Biostatistics and Statistical Programming, Principal Biostatisticians to develop and implement project management tools / tracker to automate the proper resource assignment & utilization, QC plans and timelines.
7) Develop and maintain statistical programming team using R / Python.
**Customer:**
Work closely with Global Medical Affairs biostatisticians to identify statistical analysis needs and assist in developing assigned deliverables.
**About you**
**Experience** : Master's degree minimum 8 years/B.Sc. minimum 10 years of relevant experience required
**Soft skills:** Stakeholder management, Ability to manage timelines and Ability to work independently and within a team environment, Autonomy in the management of activities; ability to manage multiple conflicting high priority deadlines
**Technical skills** : Advance SAS programming skills, SDTM & ADaM (CDISC) and clinical data environment across multiple therapeutic areas
**Education** : Bachelor or Master of Science degree or equivalent in Statistics, Computer Science, Mathematics, Engineering, Life Science, or related field.
**Languages** : Excellent English language knowledge - written and spoken
**Pursue progress, discover extraordinary**
Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.
Watch our ALL IN video ( and check out our Diversity Equity and Inclusion actions at sanofi.com ( !
**Pursue** **_progress_** **, discover** **_extraordinary_**
Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video ( and check out our Diversity Equity and Inclusion actions at sanofi.com ( !
Global Terms & Conditions and Data Privacy Statement ( is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting or via our movie We are Sanofi ( an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live.
All in for Diversity, Equity and Inclusion at Sanofi - YouTube (
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