Associate Director Biostatistics
1 day ago
- 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.
- 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 statistician's work
- 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.
- 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.
- Vast opportunities to learn and develop within our global organization
- Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
- Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
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