Biostatistics Director_

Washington D.C.

**HOW MIGHT YOU DEFY IMAGINATION?**

If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.

**Accountabilities**

•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 Strategic Development Director, Director, Statistical Innovation, EDL, GDL, GMAL, and Regional Medical Leads

•Partner with evidence-related, cross-functional stakeholders to ensure the highest statistical standards and integrity and provide program level statistical support

**Responsibilities**

**Statistical Excellence**

•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 in balance with speed, quality, and cost for designated products / programs

•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 as well as other potential applications of innovations (e.g., collaborations with CfOR and HEOR)

•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

•Partner with evidence-related, cross-functional stakeholders to ensure the highest statistical standards and integrity and provide program level statistical support for HTAs and payer negotiations, regulatory submissions RTQs, safety and benefit-risk assessment, and scientific publications

•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)

**Resource Management**

•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

**Qualifications**

**Basic Qualifications**

Doctorate degree and 4 years of experience OR

Master’s degree and 7 years of experience OR

Bachelor’s degree and 9 years of experience

**Preferred Qualifications**

•Doctorate in Statistics/Biostatistics and 8 years of post-graduate statistical experience in the pharmaceutical industry or medical research, and inflammatory/autoimmune and/or rare disease area of at least 4 years

Or

•Master’s degree and 12 years of Biostatistics experience in the pharmaceutical industry or medical research, and inflammatory/autoimmune and/or rare disease area of at least 4 years

•

•Participation in regulatory interactions

•Statistical technical and strategic leadership / contribution to regulatory / reimbursement submissions

•People Management experience

•Life Cycle Drug Development Experience

•Independent leadership of multiple projects

•Experience working effectively in a globally dispersed team environment with cross-cultural partners

•Excellent oral and written communication skills

•Thorough understanding of regulatory and industry trends

•Experience developing policies and SOPs

•Scientific research/publications in one or more areas of statistical science

**Competencies**

**Scientific / Technical Excellence:**

•Superior understanding of statistical principles, methods, applications, and procedures and can apply innovative study design

•Leads and instructs others in statistical areas relating to randomized and non-randomized clinical research

•Excellent analytical and problem-solving skills

•Deep understanding of drug development process and operations

•Highly proficient in biostatistical software

•Excellent business acumen and strategic thinking skills

**People / Project Management** **:**

•Communicates complex and nuanced statistical information in a concise and impactful way—including to lay audiences

•Successfully leads cross-functional teams across geographies;

•Excellent organization skills

•Able to navigate in a large global, matrixed organization

•Demonstrates ability to identify and adapt to shifting priorities and competing demands

•Manages teams (including external service providers) to tasks and timelines

**Thrive**

**What you can expect of us**

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

+ 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, or for field sales representatives, a sales-based incentive plan

+ Stock-based long-term incentives

+ Award-winning time-off plans and bi-annual company-wide shutdowns

+ Flexible work models, including remote work arrangements, where possible

**Apply now**

**for a career that defies imagination**

Objects in your future are closer than they appear. Join us.

**careers.amgen.com**

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.