Develop and deliver analysis-ready datasets, tables, listings, and figures for clinical studies using statistical programming. Ensure high-quality code, documentation, and QC; collaborate with statisticians and leads; apply ICH and regulatory standards and clinical data standards to support study and asset-level deliverables.
Job Description
A productive, hands on programmer who applies technical knowledge and practical experience to deliver statistical programming deliverables to support assets and study teams with limited supervision early in role and independently later in role.•
Ensures excellence in the programming of analysis ready datasets, tables, listings, and figures for which they are responsible•
Ensures adherence to high quality programming standards in their daily work. Accountable for the quality and timely delivery of datasets and displays required for their clinical study reports as well as other asset level deliverables they may be programming.
Ensures appropriate documentation and QC across the lifespan of the study for all of their programming deliverables.
Exhibits routine and occasionally complex problem solving skills, seeking direction when appropriate.•
Works with statisticians and programming leads to ensure clear specifications for their programmed deliverables are in place.
Will be knowledgeable in core safety standards as well as TA standards pertinent to their project, may aid in development of standards necessary for their study
May contribute to department level initiatives.
QUALIFICATIONS
Bachelor or Master (preferred) Degree in Statistics, Biological Sciences, IT, or related field.•
At least 3 years relevant experience in a pharmaceutical, biotech, CRO, or Regulatory Agency.•
Statistical Programming and SAS hand-on experience•
Clinical trials expertise with an understanding of data operations required for the reporting of clinical trial data.•
Good understanding of ICH and regulatory guidelines•
Working knowledge of clinical data and relevant data standards
Work Location Assignment: Flexible
Work Location Assignment: Flexible
Work Location Assignment: Hybrid
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers .
Medical
#BI-Hybrid
A productive, hands on programmer who applies technical knowledge and practical experience to deliver statistical programming deliverables to support assets and study teams with limited supervision early in role and independently later in role.•
Ensures excellence in the programming of analysis ready datasets, tables, listings, and figures for which they are responsible•
Ensures adherence to high quality programming standards in their daily work. Accountable for the quality and timely delivery of datasets and displays required for their clinical study reports as well as other asset level deliverables they may be programming.
Ensures appropriate documentation and QC across the lifespan of the study for all of their programming deliverables.
Exhibits routine and occasionally complex problem solving skills, seeking direction when appropriate.•
Works with statisticians and programming leads to ensure clear specifications for their programmed deliverables are in place.
Will be knowledgeable in core safety standards as well as TA standards pertinent to their project, may aid in development of standards necessary for their study
May contribute to department level initiatives.
QUALIFICATIONS
Bachelor or Master (preferred) Degree in Statistics, Biological Sciences, IT, or related field.•
At least 3 years relevant experience in a pharmaceutical, biotech, CRO, or Regulatory Agency.•
Statistical Programming and SAS hand-on experience•
Clinical trials expertise with an understanding of data operations required for the reporting of clinical trial data.•
Good understanding of ICH and regulatory guidelines•
Working knowledge of clinical data and relevant data standards
Work Location Assignment: Flexible
Work Location Assignment: Flexible
Work Location Assignment: Hybrid
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers .
Medical
#BI-Hybrid
Pfizer Chennai, Tamil Nadu, IND Office
Chennai, India
Similar Jobs at Pfizer
Artificial Intelligence • Healthtech • Machine Learning • Natural Language Processing • Biotech • Pharmaceutical
Support clinical data monitoring and management activities including data review, query management, validation, and resolving data/document discrepancies. Provide first-line CTMS support, ensure database and documentation quality, follow SOPs, and contribute to process improvements and projects.
Top Skills:
ChatgptClinical Trial Management System (Ctms)Electronic Documentation Management SystemsMicrosoft CopilotMS OfficeWeb-Based Data Management Systems
Artificial Intelligence • Healthtech • Machine Learning • Natural Language Processing • Biotech • Pharmaceutical
Perform GxP-compliant analytical development, troubleshooting, and method validation for extractables/leachables and nitrosamine workflows using LC-MS, GC-MS, ICP-MS, HPLC and GC. Maintain audit-ready data packages, support QA and CAPA processes, produce technical reports, and coordinate cross-functional teams to meet milestones.
Top Skills:
GcGc-MsGchsHplcIcp-MsLc-MsWet Chemistry
Artificial Intelligence • Healthtech • Machine Learning • Natural Language Processing • Biotech • Pharmaceutical
Lead CMC regulatory activities for combination medical device products post-approval. Manage change control, track submissions and commitments, develop global regulatory strategies, advise cross-functional teams, and serve as technical CMC representative while ensuring compliance with global regulations and quality systems.
Top Skills:
AdobeChatgptDocumentumDocumentum-Based ApplicationsDossier Workflow ToolsExcelGenerative Ai ToolsMicrosoft CopilotMS OfficeWord
What you need to know about the Chennai Tech Scene
To locals, it's no secret that South India is leading the charge in big data infrastructure. While the environmental impact of data centers has long been a concern, emerging hubs like Chennai are favored by companies seeking ready access to renewable energy resources, which provide more sustainable and cost-effective solutions. As a result, Chennai, along with neighboring Bengaluru and Hyderabad, is poised for significant growth, with a projected 65 percent increase in data center capacity over the next decade.
