Statistical Programmer

3 weeks ago

India Latinum HR Solutions Full time

Job Title: Statistical Programmer Lead

Location: Mumbai / Pune / Bangalore

Experience: 5 - 12 years

Industry: Pharmaceuticals / Biotechnology / Clinical Research

About the Role

We are looking for an experienced Lead 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.

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