Biogen Head of Biostatistics and Real-World Data Analytics, R&D in Cambridge, Massachusetts
About This Role The Head of Biostatistics provides statistical leadership for all areas of clinical and pre-clinical development in the R&D development units. They have responsibility for strategic and operational leadership of the Biostatistics and Real-World Data Analytics function (>80 colleagues) in relation to people, scientific and operational excellence, and as part of a matrix leadership for the wider Analytics and Data Sciences (ADS) function. What You Will Do Responsibilities include assuming a functional leadership role as well as strong partnerships across the Biogen enterprise (e.g., other ADS functions, China and Japan R&D teams, R&D enabling functions, Development Units, World-Wide Medical, Biogen Digital Health, Value & Access, Medical Affairs, Regulatory, IT, Biogen Biosimilars unit) to: * Develop, direct and oversees activities in the areas of Biostatistics function for all development units within R&D, including the development and implementation of the Biostatistics functional strategic plan to support all portfolio goals * Be accountable for the financial and operating performance of the Biostatistics and Real World Data Analytics function, including maintaining budget, staffing, quality (e.g., CAPAs), and functional deliverables within agreed targets * Build out a new function focused on endpoint/eCOA development * Provide leadership to the Biostatistics and Real World Data Analytics organization directly as well as indirectly through the Biostatistics Leadership Team * Serve as a core member of the Analytics and Data Sciences (ADS) Leadership Team and contribute to the establishing and accomplishing of the vision and goals of ADS. They will clearly communicate the vision and goals for Biostatistics and Real World Data Analytics and the wider organizational goals of ADS to their organization * Ensure performance management and career development of Biostatistics and Real World Data Analytics colleagues reflecting a culture of open, real-time feedback aimed at the growth of individuals * Represent Biostatistics and Real World Data Analytics (and/or ADS) at relevant governance/review forums, where appropriate. * Evaluate key business challenges, analyze long-term impact of, and provide advice related to, new or innovative solutions through the application of in-depth and evolving knowledge of Biostatistics and Real World Data Analytics. Drive focused innovation to support both the current and future Biogen portfolio and evolving scientific and regulatory environment * Engender an inspiring, empowered, proactive and accountable culture within the Biostatistics and Real World Data Analytics function that is aligned to the Biogen Elements Required Skills: * A doctoral degree (or equivalent) in statistics, biostatistics, or closely related field * At least 15 years’ experience in biotech, pharmaceutical, CRO or related industry * Experience leading teams in the field of statistics, biostatistics and/or related fields in a direct-reporting relationship. * Demonstrated success in providing quantitative leadership across all phases of drug development and expertise in the design, analysis, and reporting of clinical trials in a regulated environment. * Expert knowledge of statistical issues, diverse methodologies and quality/compliance regulations related to the development of novel therapies. * Demonstrated success in advising and guiding teams on key methodological questions and clarity in defining key clinical questions of interest. * Demonstrated success in matrixed leadership, ability to lead large organizations, influence peers with strong statistical, scientific and strategic business acumen * Proven skills around real world evidence generation from diverse sources, and use in clinical trial design * Experience interacting with academia, thought leaders, health systems, payers and regulatory agencies * Excellent organizational, collaboration and communication skills Preferrred Skills * Firm understanding of the uses of evidence-based medicine and comparative effectiveness analyses for both internal and regulatory decision-making * Experience with real-world data analytics, use of real-world data for regulatory purpose and/or use of external historical control data for efficient clinical study design * Experience with principles of endpoint/clinical outcome assessment development, either directly or via third party providers * Specific experience in the field of Neuroscience and in global submissions is desirable. This position is hybrid and requires some frequent office presence to Biogen's Cambridge, MA offices. LI-RD8 *Why Biogen Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.