What are the responsibilities and job description for the BIOSTATISTICS DIRECTOR position at Amgen?
If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of.
- Accountabilities
- Responsibilities
- Statistical Excellence
- Resource Management
- Qualifications
- Basic Qualifications
- Preferred Qualifications
- Competencies
- Scientific / Technical Excellence :
- People / Project Management
- Thrive
- What you can expect of us
- 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
- careers.amgen.com
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
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)
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
Doctorate degree and 4 years of experience OR
Masters degree and 7 years of experience OR
Bachelors degree and 9 years of experience
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
Masters 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
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
Communicates complex and nuanced statistical information in a concise and impactful wayincluding 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
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 :
Objects in your future are closer than they appear. Join us.
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.
