Location: Pan India (Onsite)
Experience: 5–12 Years
We are hiring for a leading global organization and seeking experienced Statistical Programmers with strong expertise in clinical trial data analysis, programming, and regulatory submissions.
Key Responsibilities
- Develop, validate, and maintain statistical programming deliverables for clinical studies.
- Create and validate SDTM and ADa M datasets in compliance with CDISC standards.
- Generate and validate Tables, Listings, and Figures (TLFs) for clinical study reports.
- Prepare and support submission deliverables including Define.xml, Reviewer Guides, and related documentation.
- Develop and maintain SAS programs, macros, and validation processes.
- Utilize R programming for statistical analysis, data visualization, and reporting.
- Support regulatory submissions to global health authorities including FDA and EMA.
- Collaborate closely with Biostatistics, Data Management, Clinical Operations, and Regulatory teams.
- Ensure adherence to industry standards, SOPs, and regulatory requirements.
Required Skills & Qualifications
- 5–12 years of experience in Statistical Programming within the Pharmaceutical, Biotechnology, or CRO industry.
- Strong hands-on experience with SAS Programming and R Programming.
- In-depth knowledge of CDISC standards (SDTM & ADa M).
- Experience in developing and validating TLFs, Define.xml, and Reviewer Guides.
- Valuable understanding of clinical trial processes and regulatory submission requirements.
- Experience supporting FDA and EMA submissions.
- Strong analytical, problem-solving, and communication skills.
Preferred Experience
Candidates with experience in any of the following therapeutic areas will be preferred:
- Oncology
- Immunology
- Neuroscience
Why Join?
- Opportunity to work on global clinical development programs.
- Exposure to complex clinical studies and regulatory submissions.
- Collaborative and high-performing work environment.
- Career growth within a leading life scien