Biogen Associate Director, Biostatistics in Cambridge, Massachusetts
About this role As the Associate Director of Biostatistics, you will be responsible for providing the statistical expertise and managing the activities for one or more clinical programs, to ensure valid and efficient study designs that allow clearly interpretable results, and timely delivery of analyses, reports and regulatory documents with high quality. You will build and maintain strong collaboration with key stakeholders from different disciplines across the organization to develop agile and robust clinical development plans and decision framework. You will provide responses to statistical issues arising in regulatory, other legal settings, or external development partners. You will provide direct supervision and mentorship and takes accountability for one or more biostatisticians including assignments, priority setting, and strategic directions and ensures the adherence of standard processes. You will also contribute to the long-term growth strategy of the department by participating in process improvement initiatives and keeping up to date of and contributes to the current statistical methodology development. What you’ll do * Key player in the strategic planning and execution of the clinical development plan for the assigned project; provide strategic contributions to the clinical studies in the program, including study designs, protocol development, statistical analysis plans, data analysis and reporting, as well as key contributions to the planning and delivery of clinical components of regulatory submissions including INDs, BLAs, NDAs and MAAs. * Manage assigned staff and FSPs statisticians to ensure quality and consistency of the deliverables; provide guidance and support to facilitate their development and enhanced efficiency; provide regular feedback to staff and ADS management * Provide key strategic contributions in addressing and statistical issues from regulatory, legal or other challenges to the company's products or processes and represents the biostatistics of the company in key regulatory meetings or meetings with KOLs as required. * Serve as peer reviewer for material authored or coauthored by other statisticians and other clinical research personnel (protocols, CSRs, regulatory documents, and manuscripts), and acts as an internal consultant as assigned on broad statistical issues that impact on the pharmaceutical/Biotechnology industry * Participate in approved process improvement initiatives; keeps up to date on current statistical methodology development and regulatory environment Who you are: You are an Associate Director with statistical expertise and have experience in managing the activities of clinical programs. You can develop innovative/creative statistical/technical solutions to complex problems and have strong verbal and written communication skills Required Skills: * PhD in Biostatistics/Statistics or equivalent with a minimum of 6-7 years relevant work experience or MS in Biostatistics/Statistics with a minimum of 8-9 years relevant experience * Substantial past regulatory interactions. * Broad and thorough understanding of statistical principles and clinical trial methodology; able to practice and implement them. * Knowledge and experience in meeting regulatory guidelines, both FDA and international regulatory agencies. * Broad knowledge of medical/biological terminology and clinical trial designs in relevant therapeutic areas. * Leadership skills in proactive strategy setting, priority evaluations, adapting to changes, conflicts resolutions, and effective partnership. 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. All your information will be kept confidential according to EEO guidelines.