Director of Biostatistics PK/PD (743999827789328)
At Biogen, we offer a workplace that is unique, connected, resilient and impactful. Our purpose to find cures for rare diseases is a unique focus within our industry. We are connected as a team by this shared purpose, the pride we have in our work, and the inspiration we obtain from the lives we’re changing. We are resilient as we overcome obstacles, following the science to deliver for our patients. Most of all, our work allows us to have an impact. An impact on our patients’ lives and on changing the course of medicine.Job Description
About this role
The Director of Biostatistics is accountable for statistical consulting and support for clinical pharmacology and pharmacokinetics studies as well as PK/PD modeling and simulations.
As the Director of Biostatistics, you will provide direction and oversight on clinical development plans, protocols, and analysis, reviews clinical study reports and regulatory submission materials, and ensures the adherence to standard procedures. You will provide direct contributions as appropriate to complex statistical analysis plans and interim analysis approaches to gain alignment across organization. The Director builds and maintains strong collaboration with key stakeholders from different disciplines across the organization to facilitate agile and robust clinical development plans and decision framework. You will also interact with clinical pharmacology, statistical programming, and data management to synchronize prioritization of projects and in some cases, you will represent Biostatistics in meetings with executive committee, R&D governance committee, regulatory agencies, advisory boards and external development partners as appropriate.
As the Director of Biostatistics, you will provide mentorship to biostatisticians in the department and facilitates consistent statistical approaches across teams and locations. You will also provide leadership for the department in achieving visions and goals, including driving process improvement initiatives and enhancement of technical capabilities of the department.
What you’ll do
- Provide statistical consulting for the projects assigned including implementing efficient, consistent, and practical processes for Biostatistics
- Provide guidance and direct input into strategy, planning and contents of clinical development plan as well as key components of regulatory submissions. Strive to increase the scientific agility by facilitating the implementation of innovative approaches and increase operational efficiency by close monitoring of the operating procedures and strategies for Biostatistics. Serve as the primary functional reviewer of protocols, analysis plans, and clinical study reports
- Provide guidance and support for all biostatisticians in assigned projects; develop staff through coaching and training. Provide broader mentoring and guidance to ensure that the Biostatistics/ADS missions and goals are achieved
- Provide guidance and direct input in addressing and statistical issues from regulatory, legal, or other challenges to the company's products or processes and represent the biostatistics of the company in key regulatory meetings or meetings with KOLs
- Participates in and/or leads cross-functional initiatives representing ADS. Participates in key R&D governance meetings and may represent
- PhD in Biostatistics/Statistics or equivalent with a minimum of 8 years relevant work experience or MS in Biostatistics/Statistics with a minimum of 10 years relevant experience
- Substantial past regulatory experiences, including interactions with FDA, EMA, and PMDA and BLA/NDA/MAA submission experiences.
- Broad and thorough understanding of statistical principles and clinical trial methodology; able to practice and implement them
- Extensive experiences in PK/PD modeling and simulations
- Ability to develop innovative/creative statistical/technical solutions to complex problems
- Knowledge and experienced in meeting regulatory guidance, both FDA and international regulatory agencies
- Broad knowledge of medical/biological terminology and clinical trial design in relevant therapeutic areas
- Strong verbal and written communication skills. able to explain methodology and consequences of decisions in lay terms
- 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.