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:
Solid 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