Clinical Statistical Programmer

2 days ago

Pune, Maharashtra, India Latinum HR Solutions Full time ₹ 20,00,000 - ₹ 25,00,000 per year

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

Location
: Mumbai / Pune / Bangalore

Experience
: 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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