Senior Manager Biostatistics in Clinical Research department

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 environment 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.