Statistical Programmer

Job Title: Statistical Programmer – Clinical Data (SAS/R)

Location: Pan India

Experience: 3 – 12 years

Industry: Pharmaceuticals / Biotechnology / Clinical Research

About the Role

We are looking for an experienced Statistical Programmer to oversee programming activities for clinical trials, regulatory submissions, and integrated analyses. This role involves leading a team, ensuring high-quality deliverables, and developing efficient programming standards to support drug development.

Key Responsibilities

- Lead statistical programming activities for a compound or therapeutic area. - Manage, mentor, and guide a team of statistical programmers. - Create and validate analysis data sets (ADaM), tables, listings, and figures (TFLs) following CDISC standards. - Develop and validate Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE) reports. - Ensure accuracy and consistency across clinical studies and integrated data. - Develop, test, and implement reusable standard programs and SAS macros to automate routine tasks. - Prepare reviewer guides, data definition documents, and other materials for regulatory filings. - Collaborate with cross-functional teams including Statisticians, Clinical Data Management, Medical Writing, Regulatory, and Clinical Operations. - Accurately estimate programming efforts and ensure timely project delivery.

Required Skills

- Strong proficiency in SAS programming; experience with R preferred. - In-depth knowledge of CDISC standards (ADaM, SDTM). - Experience with regulatory submissions (FDA, EMA) and clinical study lifecycle. - Knowledge of therapeutic areas such as Oncology, Immunology, Neuroscience. - Strong communication and leadership skills to guide teams and manage stakeholders. - Ability to handle multiple priorities and deliver high-quality results under deadlines.

Why Join Us?

- Work on cutting-edge clinical trials and regulatory submissions. - Collaborate with a team of top-tier professionals. - Opportunity to develop advanced programming frameworks and drive innovation in data analytics.