Biostatistics Director
- Employer
- Amgen
- Location
- Washington D.C., District of Columbia
- Start date
- Oct 30, 2024
View more categoriesView less categories
- Discipline
- Science/R&D, Biostatistics
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Best Places to Work
Job Details
HOW MIGHT YOU DEFY IMAGINATION?
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
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 LeadsPartner with evidence-related, cross-functional stakeholders to ensure the highest statistical standards and integrity and provide program level statistical supportResponsibilities
Statistical Excellence
Understand, promote, and communicate innovative and standard statistical methodologies, trial design, data analysis, and medical / clinical understanding for productPartner 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 / programsPartner 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 EGPOversee 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 documentationPartner 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 publicationsProvide strategic input and be the key biostatistics contact for regulatory queries and interactions with regulatory agencies in collaboration with the Principal StatisticianContribute to statistical strategy with other analytical groups (e.g. PK/PD modelling strategy, biomarker analysis plan)Resource Management
Lead global biostatistics teamLead in the achievement of annual department goalsManage and develop staffEnsure Biostatistics team effectively utilize assigned supplier resources Oversee development of Amgen Policies, SOPs and other controlled documentsQualifications
Basic Qualifications
Doctorate degree and 4 years ofexperience OR
Masters degree and 7 years ofexperience OR
Bachelors degree and 9 years ofexperience
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 yearsOr
Masters degree and 12 years of Biostatistics experiencein the pharmaceutical industry or medical research, and inflammatory/autoimmune and/or rare disease area of at least 4 yearsParticipation in regulatory interactionsStatistical technical and strategic leadership / contribution to regulatory / reimbursement submissionsPeople Management experience Life Cycle Drug Development ExperienceIndependent leadership of multiple projectsExperience working effectively in a globally dispersed team environment with cross-cultural partnersExcellent oral and written communication skillsThorough understanding of regulatory and industry trendsExperience developing policies and SOPsScientific research/publications in one or more areas of statistical scienceCompetencies
Scientific / Technical Excellence:
Superior understanding of statistical principles, methods, applications, and procedures and can apply innovative study designLeads and instructs others in statistical areas relating to randomized and non-randomized clinical researchExcellent analytical and problem-solving skillsDeep understanding of drug development process and operationsHighly proficient in biostatistical softwareExcellent business acumen and strategic thinking skillsPeople / Project Management:
Communicates complex and nuanced statistical information in a concise and impactful wayincluding to lay audiences Successfully leads cross-functional teams across geographies;Excellent organization skillsAble to navigate in a large global, matrixed organizationDemonstrates ability to identify and adapt to shifting priorities and competing demandsManages teams (including external service providers) to tasks and timelinesThriveWhat 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
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
careers.amgen.comAmgen 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.
Company
We are all different, yet we have this in common: our mission to serve patients. This sense of shared purpose is key to our becoming one of the world’s leading biotechnology companies. It guides us as we continue to launch new medicines and reach millions of patients worldwide.
We live the mission.
We win together.
We thrive on continual challenge.
Our team of 22,000+ scientists and professionals worldwide bring distinct perspectives and experiences to all we do. We leverage our global talent to achieve together—to research, manufacture and deliver ever-better products and greater depth to our mission.
At Amgen, there is a strong correlation between our high level of diversity and performance. Because addressing issues with a wider range of perspectives and approaches leads to more creative problem-solving. Together, we’re transforming the promise of science and biotechnology into therapies that have the power to restore health.
Connect with us to explore how you can Win, Live, and Thrive at Amgen.
- Website
- http://careers.amgen.com/
- Phone
- 805-447-1000
- Location
-
Corporate Headquarters
One Amgen Center Drive
Thousand Oaks
California
91320-1799
United States
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