Amgen Inc. is hiring a Director Biostatistics to lead the statistical program strategy for a portfolio of complex development programs. You will serve as the primary point of contact for statistical excellence, influencing the product lifecycle and ensuring the highest standards in evidence generation within our collaborative, science-based culture.
What You'll Do
- Develop, lead, and serve as the primary point of contact for the statistical program strategy for a portfolio of complex programs.
- Influence across product life cycle through developing statistically compelling Evidence Generation Plans (EGP) in collaboration with cross-functional leads.
- Partner with evidence-related, cross-functional stakeholders to ensure the highest statistical standards and integrity and provide program level statistical support.
- Understand, promote, and communicate innovative and standard statistical methodologies, trial design, data analysis, and medical/clinical understanding for product.
- Partner with CfDA Design & Innovation to drive novel designs and fit-for-purpose statistical approaches, standards, technical quality, study design, analysis, interpretation and evidence synthesis.
- Partner with Strategic Development Director / Director, Statistical Innovation / EDL / GDL / GMAL / PT to define the data and evidence requirements for product lifecycle and translate it into the EGP.
- Oversee creation of Global Statistical Strategic Plan (GSSP) to align program design and statistical approaches with product strategy and EGP.
- Oversee statistical contributions to key design elements, protocols, randomization specifications, statistical analysis plans, tables, figures and listings shells, submission data file specifications, and other key product-related documentation.
- Provide strategic input and be the key biostatistics contact for regulatory queries and interactions with regulatory agencies in collaboration with the Principal Statistician.
- Contribute to statistical strategy with other analytical groups (e.g. PK/PD modelling strategy, biomarker analysis plan).
- Lead global biostatistics team.
- Lead in the achievement of annual department goals.
- Manage and develop staff.
- Ensure Biostatistics team effectively utilize assigned supplier resources.
- Oversee development of Amgen Policies, SOPs and other controlled documents.
What We're Looking For
- Doctorate in Statistics/Biostatistics and at least 8 years of post-graduate statistical experience in the pharmaceutical industry or medical research.
- Master’s degree in Statistics/Biostatistics or related subject with high statistical content and at least 10 years of post-graduate statistical experience in the pharmaceutical industry or medical research.
Nice to Have
- Doctorate in Statistics/Biostatistics and 8 years of post-graduate statistical experience in the pharmaceutical industry or medical research in Oncology/Hematology therapy area of at least 4 years.
- Master’s degree and 12 years of Biostatistics experience in the pharmaceutical industry or medical research in Oncology/Hematology therapy area of at least 4 years.
Team & Environment
You will lead the global biostatistics team, managing and developing staff to achieve department goals.
Benefits & Compensation
- Compensation: $240,284 - $280,634 (expected annual salary range for San Francisco). Actual salary varies based on skills, experience, and qualifications.
- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
- A discretionary annual bonus program.
- Stock-based long-term incentives.
- Award-winning time-off plans.
- Flexible work models, including remote and hybrid work arrangements, where possible.
Work Mode
This role is hybrid and based in San Francisco.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
