Senior Manager Biostatistics - Clinical Research

About the Company

Ipca is a fully integrated pharmaceutical organization engaged in producing, marketing, and distributing Active Pharmaceutical Ingredients, pharmaceutical formulations, and medicinal products globally.

Role Overview

This position seeks a Senior Manager or Assistant General Manager in Biostatistics within the Clinical Research and Bioequivalence sectors.

Qualifications and Experience

• A Master's degree in Statistics or Biostatistics is essential.
• Between 10 to 15 years of pertinent experience in Clinical Research, Bioequivalence studies, and the field of Biostatistics.
• Experience in pharmaceutical or Contract Research Organization (CRO) settings is preferred.

Key Responsibilities

• Offer statistical expertise in designing Clinical and Bioequivalence studies, including sample size calculations and design recommendations.
• Critically evaluate study protocols to ensure statistical method validity and accuracy.
• Review and authorize randomization plans and schedules prepared by statisticians.
• Conduct statistical analyses personally and provide independent review of statisticians' analytical outputs.
• Provide mentorship and guidance to statisticians on preparation of Statistical Analysis Plans, programming, data evaluation, and Statistical Analysis Reports.
• Ensure all statistical operations comply with ICH-GCP standards, regulatory requirements, and internal standard operating procedures.

Essential Skills

• In-depth knowledge of clinical trial designs, bioequivalence study frameworks, and applied statistical methods.
• Proficiency in sample size calculations, randomization methodologies, and comprehensive statistical data analysis.
• Hands-on expertise with SAS programming; familiarity with R programming is an advantage.