Senior Biostatistician

ANY WHERE IN INDIA  |  Full-time  |  6 years

Job Description

  • Provide statistical input for protocol development, study design, and sample size calculation.
  • Develop the Statistical Analysis Plan (SAP), including derived datasets, statistical tables, figures, and listings for clinical study reports.
  • Collaborate with cross-functional teams including Clinical, Regulatory, Medical Writing, and Data Management.
  • Oversee the production and quality control of randomization schedules.
  • Review Case Report Forms (CRFs) and data validation guidelines to ensure data quality and integrity.
  • Design analysis dataset specifications in accordance with the SAP, table shells, and CDISC ADaM standards.
  • Support Data Safety Monitoring Board (DSMB) / Data Monitoring Committee (DMC) activities, including charter development, analysis plans, and statistical reviews.
  • Track study milestones and ensure project deliverables are completed on schedule.
  • Identify project risks, out-of-scope activities, and escalate issues to management.
  • Ensure compliance with regulatory guidelines and industry standards.
  • Prepare and review clinical study reports and regulatory submission documents.
  • Mentor junior Biostatisticians and Statistical Programmers.

  • Stay current with advances in biostatistics, CDISC standards, GCP, and regulatory guidelines.

    • Skills Required

    CDISC Standards, ADaM, TFL Programming , SAS, R , Study Design, Statistical Analysis Plan, Sample Size Calculation , FDA Guidelines, EMA Guidelines, Compliance & Submissions

    Experience Required

    6 years

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