Senior Manager - Biostatistics

Ipca, a leading pharmaceutical company, is seeking an experienced and dedicated Senior Manager - Biostatistics to join our dynamic team in Kandivali (W), Mumbai. This pivotal role involves providing expert statistical leadership and support for our Clinical Research and Bioequivalence studies. If you possess a strong background in biostatistics within a pharmaceutical or CRO environment and are passionate about contributing to cutting-edge research, we invite you to apply.

As the Senior Manager - Biostatistics, you will be instrumental in the design, analysis, and reporting phases of clinical trials, ensuring robust statistical methodologies and regulatory compliance. You will play a crucial role in mentoring and guiding a team of statisticians, fostering a culture of excellence and continuous improvement.

Key Responsibilities

• Provide expert statistical guidance in the design of Clinical and Bioequivalence (BE) studies, including precise sample size estimation and optimal study design recommendations.
• Conduct thorough reviews of study protocols to ensure the scientific appropriateness and correctness of all statistical methodologies employed.
• Review and approve randomization plans and schedules meticulously prepared by statisticians, maintaining data integrity.
• Execute complex statistical analyses independently and rigorously review analyses performed by other statisticians to ensure accuracy and validity.
• Mentor, train, and guide statisticians in the preparation of Statistical Analysis Plans (SAPs), statistical programming, data analysis, and the development of comprehensive Statistical Analysis Reports (SARs).
• Ensure stringent compliance with ICH-GCP guidelines, relevant regulatory requirements, and internal Standard Operating Procedures (SOPs) across all statistical activities.
• Act as a subject matter expert, offering biostatistical insights and solutions to cross-functional teams involved in clinical development.
• Contribute to the continuous improvement of biostatistical processes and methodologies within the organization.

Requirements

• Master's degree (M.Sc.) in Statistics or Biostatistics from a recognized institution.
• A minimum of 10 to 15 years of progressive and relevant experience in Clinical Research, Bioequivalence studies, and Biostatistics.
• Demonstrated experience within a reputable pharmaceutical company or Contract Research Organization (CRO) environment is highly preferred.
• Strong understanding of clinical trial design principles, bioequivalence study requirements, and advanced statistical methodologies.
• Expertise in sample size determination, various randomization techniques, and comprehensive statistical analysis.
• Hands-on proficiency in SAS programming is essential; working knowledge of R programming is highly desirable.
• In-depth knowledge of ICH-GCP guidelines and global regulatory requirements pertaining to clinical trials.
• Excellent communication, leadership, and mentoring skills to guide a team of statisticians effectively.

What We Offer

• An opportunity to work on challenging and impactful clinical research projects at a leading pharmaceutical company.
• A collaborative and supportive work environment that encourages professional growth and learning.
• Exposure to advanced statistical methodologies and cutting-edge pharmaceutical development.
• Competitive compensation and benefits package reflective of your experience and expertise.
• A chance to make a significant contribution to public health through rigorous scientific research.

If you are a highly motivated Biostatistics professional ready to take on a leadership role and drive excellence in clinical research, we encourage you to apply. Join Ipca and become a vital part of our mission to deliver quality healthcare solutions.