Director, Strategic Partnerships
Medtronic
Director, Biostatistics
Amylyx Pharmaceuticals
full-time
Posted on:
Origin: • 🇺🇸 United States
Visit company websiteJob Level
Lead
About the role
- Provide strategic leadership of statistical approaches on an assigned therapeutic area or a program, shaping clinical development plans from early design through regulatory submission, and serving as a statistical thought partner to cross-functional leaders and external stakeholders.
- Design and oversee implementation of robust, innovative trial designs that maximize probability of clinical and regulatory success, balancing scientific rigor with operational feasibility, while anticipating and proactively addressing potential regulatory challenges.
- Mentor, coach, and develop statisticians at varying levels of experience by providing technical guidance, fostering professional growth, and instilling best practices in statistical methods, data integrity, and regulatory compliance.
- Synthesize and present statistical insights by preparing data packages and cross-functional presentations, effectively communicating strategies, assumptions, and implications to leadership, regulatory bodies, and scientific audiences.
- Partner closely across functions to ensure alignment, collaboration, and timely execution of statistical deliverables that enable high-quality program success.
- Engage in occasional travel (Cambridge, MA and other locations) for collaboration and conferences, typically at least three times annually.
- Liaise with internal and external stakeholders (e.g. Clinical Development, Regulatory, Pharmacovigilance, Translational Sciences, Programming and Data Management, CROs) for the implementation of a clinical development program, regulatory submissions and post-submission strategies/preparation/defense.
Requirements
- PhD in Statistics/Biostatistics, Mathematics, or related quantitative fields with a minimum of 10 years, or MSc with a minimum of 14 years of experience with clinical trials including late-phase studies.
- Proficiency in scientific computing/programming (SAS or R) and implementation of advanced statistical analyses and simulations, deep knowledge of CDISC standards.
- Proficiency in the design of clinical trials Phases I – III, in applying knowledge of general and cutting edge statistical / clinical trials methodologies to solve complex statistical problems in the clinical development programs and to ensure alignment with regulatory agencies and industry standards.
- Demonstrate skills in the analysis and reporting of clinical trials; experience with integrated summaries of safety and efficacy (ISS and ISE).
- Prior experience in interactions with regulatory and health authorities considered a plus.
- Access to work setting that meets role requirements (including privacy, reliable internet access, phone, ability to video conference, etc.) at your remote location.
- Not considering applicants who reside and/or work in Alaska, Arizona, Delaware, Hawaii and Kansas.
- Willingness to travel to Cambridge, MA and other locations, typically at least three times annually.
