About This Role
An Associate Director of Biostatistics contributes statistical strategy, operational execution, and scientific leadership across Amgen's clinical programs. You will oversee statistical contributions to clinical trials, lead study teams, and support regulatory and reimbursement submissions, while mentoring and managing statisticians.
Responsibilities
- Provide sound statistical guidance to clinical development, reimbursement, and medical affairs
- Oversee statistical contributions to protocols, randomization specifications, statistical analysis plans (SAPs), clinical study reports (CSRs), and key trial documents
- Ensure alignment of study design and analysis with scientific rigor, regulatory requirements, and Amgen policies
- Collaborate cross-functionally with global teams to deliver high-quality analyses, publications, and regulatory filings
- Contribute to innovative trial designs, advanced methodologies, and process improvement initiatives
- Execute biostatistical strategies across the product lifecycle, from early development through post-marketing
- Provide consultancy and training to colleagues across R&D
- Support governance of outsourced statistical activities, ensuring adherence to Amgen standards and regulatory compliance
- Represent Biostatistics in cross-functional and external interactions (e.g., with regulatory agencies, investigators, or data monitoring committees)
- Drive technology adoption leveraging AI capabilities to streamline statisticians' work
Requirements
- Doctorate in Statistics/Biostatistics (or related subject with high statistical content) with at least 5 years of post-graduate statistical experience in the pharmaceutical industry or medical research, OR
- Master's degree in Statistics/Biostatistics (or related subject with high statistical content) with at least 8 years of post-graduate statistical experience in the pharmaceutical industry or medical research
About the Company
Amgen is expanding its global Biostatistics capabilities, with Amgen India (AIN) playing a key role in integrated delivery and functional leadership.
