Vacancy for - Senior Manager/AGM Biostatistics (Clinical Research & Bioequivalence)

Qualification Required:

- M.Sc. in Statistics / Biostatistics (Essential)

Experience:

- 10 to 15 years of relevant experience in Clinical Research, Bioequivalence (BE) studies, and Biostatistics.
- Experience in pharmaceutical/CRO workplace preferred.

Key Responsibilities:

- Provide statistical support in the design of Clinical and Bioequivalence (BE) studies, including sample size estimation and study design recommendations.
- Review study protocols to ensure the appropriateness and correctness of statistical methodologies.
- Review and approve randomization plans and randomization schedules prepared by statisticians.
- Perform statistical analyses and independently review analysis conducted by statisticians.




- Mentor and guide statisticians in the preparation of Statistical Analysis Plans (SAPs), statistical programming,data analysis, and Statistical Analysis Reports (SARs).
- Ensure compliance with ICH-GCP, regulatory guidelines, and internal SOPs for all statistical activities.

Required Skills:

- Strong understanding of clinical trial design, bioequivalence studies, and statistical methodologies.
- Expertise in sample size determination, randomization techniques, and statistical analysis.
- Hands-on experience in SAS programming; working knowledge of R programming is desirable.

📌 Senior Manager Biostatistics in Clinical Research department (Mumbai)
🏢 IPCA
📍 Mumbai