Director, Biostatistics
Amylyx Pharmaceuticals
August 11, 2026
Remote
United States
Clinical Research and Development
Responsibilities:
- Provide strategic leadership of statistical approaches on an assigned therapeutic area/program from early design through regulatory submission and post-submission activities.
- Serve as statistical lead and thought partner to cross-functional teams and external stakeholders.
- Lead design and oversight of robust, innovative clinical trial designs to maximize clinical/regulatory success; balance rigor with operational feasibility and anticipate regulatory challenges.
- Oversee and/or contribute to statistical deliverables (protocols, statistical analysis plans, TLF shells, clinical study reports, integrated safety/efficacy summaries, briefing documents, regulatory responses, submission materials).
- Oversee CRO/vendor statistical and programming activities to ensure quality, consistency, timeliness, and regulatory alignment.
- Mentor and develop statisticians; instill best practices in statistical methods, data integrity, and regulatory compliance.
- Synthesize and present statistical insights; communicate strategies, assumptions, and implications to leadership, regulators, and scientific audiences.
- Partner across functions to ensure timely execution of statistical deliverables.
- Occasional travel to Cambridge, MA and other locations (typically ≥3x/year).
Required Qualifications:
- PhD in Statistics/Biostatistics/Mathematics (10+ years) or MSc (14+ years) with clinical trials including late-phase.
- SAS or R programming; advanced statistical analyses and simulations; deep knowledge of CDISC.
- Clinical trial design expertise (Phases I–III) and general/cutting-edge statistical methodology; alignment with regulatory/industry standards.
- Clinical trial analysis/reporting experience; integrated safety/efficacy summaries (ISS/ISE).
- Prior regulatory/health authority interaction experience (plus).
- Excellent written/verbal/interpersonal communication; strong negotiation/organizational skills; able to work independently.
- Provide strategic leadership of statistical approaches on an assigned therapeutic area/program from early design through regulatory submission and post-submission activities.
- Serve as statistical lead and thought partner to cross-functional teams and external stakeholders.
- Lead design and oversight of robust, innovative clinical trial designs to maximize clinical/regulatory success; balance rigor with operational feasibility and anticipate regulatory challenges.
- Oversee and/or contribute to statistical deliverables (protocols, statistical analysis plans, TLF shells, clinical study reports, integrated safety/efficacy summaries, briefing documents, regulatory responses, submission materials).
- Oversee CRO/vendor statistical and programming activities to ensure quality, consistency, timeliness, and regulatory alignment.
- Mentor and develop statisticians; instill best practices in statistical methods, data integrity, and regulatory compliance.
- Synthesize and present statistical insights; communicate strategies, assumptions, and implications to leadership, regulators, and scientific audiences.
- Partner across functions to ensure timely execution of statistical deliverables.
- Occasional travel to Cambridge, MA and other locations (typically ≥3x/year).
Required Qualifications:
- PhD in Statistics/Biostatistics/Mathematics (10+ years) or MSc (14+ years) with clinical trials including late-phase.
- SAS or R programming; advanced statistical analyses and simulations; deep knowledge of CDISC.
- Clinical trial design expertise (Phases I–III) and general/cutting-edge statistical methodology; alignment with regulatory/industry standards.
- Clinical trial analysis/reporting experience; integrated safety/efficacy summaries (ISS/ISE).
- Prior regulatory/health authority interaction experience (plus).
- Excellent written/verbal/interpersonal communication; strong negotiation/organizational skills; able to work independently.