Associate Director, Biostatistics

Company: Blueprint Medicines Corporation
Location: Cambridge
Posted on: November 19, 2021

Job Description:

Associate Director, Biostatistics Cambridge, MA Requisition Number: STS21-001 Blueprint Medicines is a global precision therapy company that invents life-changing therapies for people with cancer and hematologic disorders. Applying an approach that is both precise and agile, we create medicines that selectively target genetic drivers, with the goal of staying one step ahead across stages of disease. Since 2011, we have leveraged our research platform, including expertise in molecular targeting and world-class drug design capabilities, to rapidly and reproducibly translate science into a broad pipeline of precision therapies. Today, we are delivering approved medicines directly to patients in the United States and Europe, and we are globally advancing multiple programs for genomically defined cancers, systemic mastocytosis, and cancer immunotherapy. What will you do? This position is part of the Biostatistics and Data Management department, dedicated to provide support to the Medical Affairs team, responsible for statistical aspects of study designs, planning and execution of statistical analyses for non-registrational data generation including Blueprint medical sponsored trials or investigator sponsored trials. This position collaborates with colleagues across medical affairs to support publication and scientific congress activities. This individual will directly collaborate with internal and external leaders in the design, analysis, and reporting of real-word evidence generation and HEOR data. What will be your responsibilities? * Perform statistical activities in collaboration with departments across the organization on medical affairs activities, real-word evidence generation, HEOR projects, and publications. * Contribute to protocol development, including authoring of statistical methods and reviewing/editing all other sections. * Author statistical analysis plans for clinical trials, and author/edit mock tables, listings, and figures. * Review Case Report Form Designs to ensure data collection meet the study objectives and the requirements of statistical analyses. * Provide analysis support for publications, including manuscripts, posters, and oral presentations. * Contribute to clinical study reports, including authoring of statistical sections and interpretation of study results. * Work on complex statistical problems. Exercise independent judgment in selecting and adapting, as needed, methods appropriate for the specific objectives. * Lead strategically within the organization, using professional concepts and principles to achieve objectives in creative and effective ways. * Coordinate activities across the biostatistics and medical affairs functions. * Provide requirements and oversight to external biostatisticians/statistical programmers, data managers and other relevant functions at CROs to ensure high quality results. * Participate in department and cross-functional meetings to optimize clinical study designs, endpoints, and analysis strategies. * Keep abreast of new developments in statistics, drug development, HEOR, and real-word evidence generation, through literature review, conference attendance, etc. * Review of IST (Investigator Sponsored Trials) statistical plans and participate on review committees. * Support ISTs for the review of external protocols. What qualifications do we require? * PhD in statistics or a related field with at least 5+ years in the pharmaceutical industry, or MS in statistics or equivalent with 8+ years of medical affairs experience in the pharmaceutical industry. * Professional proven understanding of theoretical and applied statistics. What qualifications do we prefer? * Experience in oncology clinical research is strongly desired. What capabilities do you bring? * Knowledge of statistical methods that apply to clinical trials, real-word data generation, and HEOR data analyses. * Proven experience partnering with CROs. * Strong statistical programming and analysis skills in SAS and/or R. * Capability to seek complex statistical problems. * Experience with trial design software (e.g., EAST); shown understanding of Spotfire is desired. * Strong interpersonal skills and excellent written/oral communication skills including grammatical/technical writing skills. * Self-motivation and self-confidence are essential. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Who we are: We don't think in small steps. We think in giant leaps. We are driven by the pursuit of new ideas, new innovations, and new ways of thinking. We know that what each and every one of us matters and that our success depends on our ability to work together in a diverse community. We believe we are at our best as a company when our employees are thriving and foster a culture that provides opportunities to grow and develop professionally, while also having fun.

Keywords: Blueprint Medicines Corporation, Cambridge , Associate Director, Biostatistics, Executive , Cambridge, Massachusetts