Biostatistics Director

, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Biostatistics Director

What you will do

Let's do this. Let's change the world. In this vital role you will 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

• 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)

• Coordinate creation of Global Statistical Strategic Plan (GSSP) to align program design and statistical approaches with product strategy and EGP

• Coordinate 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)

• Lead global biostatistics team

• Lead in the achievement of annual department goals

• Manage and develop staff

• Ensure Biostatistics team effectively use assigned supplier resources

• Coordinate development of Amgen Policies, SOPs and other controlled documents

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications.

Basic Qualifications:

Doctorate degree and 4 years of relevant experience

OR

Master's degree and 7 years of relevant experience

OR

Bachelor's degree and 9 years of relevant 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

• 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

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of 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 that may include:

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

• Stock-based long-term incentives

• Award-winning time-off plans

• Flexible work models, including remote and hybrid work arrangements, where possible

Apply now

for a career that defies imagination

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

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.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

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.

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.

Salary Range
192,257.00 USD - 222,113.00 USD