Biogen Sr. Director, Biostatistics in Cambridge, Massachusetts
The Senior Director of Biostatistics is responsible for the overall Biostatistics function of key Biogen thereapeutic areas in clincal development unitHe/She develops and oversees the therapeutic areas’ strategy and directions to ensure high scientific integrity and operation efficiency of Biostatistics elements of the clinical development across indications. He/she, in collaboration with clinical research and other key stakeholders, sets development strategy and advances innovations for Biogen assets in the responsible therapeutic areas. He/she is accountable for biostatistics components of regulatory submissions, including briefing documents, responses to questions, and NDA/BLA/MAA filings. He/she may represent Biostatistics at the corporate level in conjunction with VP, ADS or as a delegate of VP, ADS. He/She provides leadership for the department in achieving visions and goals, including driving process improvement initiatives and enhancement of technical capabilities of the department. He/she establishes detailed data-driven resource plans and spearheads the recruitment of high caliber candidates. He/She engages with other ADS sub-functions to continuously enhance the data and analytics capabilities of ADS and engages with other R&D functions for cross-funcational initiatives. He/she fosters inclusive, collaborative, and agile culture of the department, provides mentorship to biostatisticians and leads consistent statistical approaches across teams and locations. 1. Develops, directs and oversees activities in the areas of Biostatistics function for the assigned development unit , including the development and implementation of strategic organizational and staffing plans to ensure high quality and on time completion of all deliverables 2. Serves as a key member of the statistical leadership team and contributes to the establishment and accomplishing of the viosn and goals of Biostatistics and ADS. Clearly communicates the visions and goals to the his/her assigned team. Manages the performance and career development of staff and provides regular guidance to encourage engaging and collaborative culture. 3. Engages other functional areas within ADS to enhance collaboration that leads to innovations, agile and clear processes, and overall productivity of ADS 4. Engages other functional areas within R&D to set drug development strategies that increase the probability of success 5. Represents the company in interactions with the regulatory agencies, corporate partners and CROs on the biostatistical aspect of the product development · PhD in Biostatistics/Statistics or equivalent with a minimum of 14 years relevant work experience or MS in Biostatistics/Statistics or equivalent with a minimum of 16 years relevant experience · Broad and thorough understanding of statistical principles and clinical trial methodology; able to practice and implement them · Able to develop innovative/creative statistical/technical solutions to complex problems · Extensive knowledge and experienced in meeting regulatory guidelines, both FDA and international regulatory agencies · Broad knowledge of medical/biological terminology and clinical practice in relevant therapeutic areas · In-depth experiences in the clinical development process and the role of biostatistics · Effective communicator: able to explain methodology and consequences of decisions in lay terms; able to understand requests for complex analyses, etc. · Effective team player; willingness to go the extra distance to get results, meet deadlines, etc. · Able to manage many projects simultaneously, to manage conflicting priorities, and to be flexible when priorities change · Strong ability to motivate staff and ensure productivity and smooth operation in conditions with ambiguity · Leadership skills in proactive strategy setting, priority evaluations, adapting to changes, conflicts resolutions, and effective partnership · Strong people manager with track record of staff development All your information will be kept confidential according to EEO guidelines.