Amgen Director, Statistical Innovation(DSI) in Thousand Oaks, California

Director of Statistical Innovation (DSI) provides critical expertise and leadership in the design and planning of innovative development programs and clinical trials. DSI is a key driver to ensure thorough consideration of innovative and conventional design options and selection of optimal design with scientific rigor and operational efficiency to increase the probability of success of clinical trials and the development program. DSI provides statistical leadership and consultation to the product Evidence Generation team (EGT) and the study design working group in evaluation of design options and other innovative approaches by synthesizing and interpreting simulation results and provides advisory input in partnership with the Global Development Lead (GDL), Global Statistical Lead (GSL), and Strategic Development Director (SDD).

Advises Product Strategy and Study Design

  • Promotes innovative design options and fit-for-purpose analysis approaches that address appropriate clinical questions in protocol / program design and balance speed, quality, and cost

  • Provides advisory input in the development of the Global Statistical Strategic Plan (GSSP) to align study design and statistical approaches with product strategy and Evidence Generation Plan (EGP)

  • Reviews key phase 2 and 3 protocols and provides input during the TA TRC review

Provides Technical Expertise

  • Provides technical expertise to GSL and EGT on innovative study designs and advanced analytical methods

  • Provides design options and simulation specifications to the Simulation and Modeling team and develops and approves the simulation plan and results

  • Interprets and communicates modeling and simulation results to inform and guide the selection of optimal trial designs

  • Provides guidance and training to the Simulation and Modeling biostatisticians.

Builds Cross-functional Network

  • Develops strong partnerships with SDDs, GSLs and the Modeling and Simulation team to ensure a CfDA 'team' approach when interacting with product teams

  • Builds relationships with counterparts in EGTs to help drive the importance of Design consultation throughout the end-to-end clinical development process

  • Builds relationships with TA TRC members to ensure alignment in development strategies

Promotes the advancement of innovative designs and analysis methods

  • Builds professional network with external experts in innovative designs and analysis methods

  • Promotes awareness of innovative designs and analysis methods by organizing and providing internal training sessions

Qualifications

Doctorate degree and 4 years of Statistics/Biostatistics experience

OR

Master's degree and 8 years of Statistics/Biostatistics years

OR

Bachelor's degree and 10 years of Statistics/Biostatistics experience

Preferred Qualifications

  • Master's or doctorate degree in Statistics/Biostatistics or related subjects with highly statistical content

  • 10 years of post-graduate statistical experience in the biopharmaceutical industry in clinical trial design, execution, analysis and reporting

  • Statistical expertise and leadership across drug development phases, regulatory submissions, and payer interactions

  • 5 years of strategic statistical leadership at product level of one complex program or multiple programs of moderate complexity

  • Excellent computing, modelling and simulation skills using R, SAS, WinBugs, FACTS, etcDoctorate in Statistics/Biostatistics and post-graduate statistical experience in the pharmaceutical industry or medical research

  • Solid experience with both conventional and innovative trial designs (including adaptive and/or Bayesian) in different phases of drug development

  • Expertise in advanced statistical analysis methods, modeling and simulation

  • Knowledge of multiple disease areas and related regulatory guidelines

  • Experience in leading regulatory and/or reimbursement submissions

  • Drive for innovation and quick adaptation to new industry trends

  • Well recognized statistical and strategic leadership among statisticians and cross-functional teams

  • External visibility in biostatistics profession (e.g., through industry committees/forums, links to academia)

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

  • Strong technical and effective communication skills

  • Managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

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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, or disability status.