Senior Director, Biostatistics & Clinical Strategy

Amylyx Pharmaceuticals; Cambridge (MA); Hybrid; USD 221,000 - 249,000; Full time

Job summary

Amylyx Pharmaceuticals is seeking a Director of Biostatistics to oversee statistical leadership in clinical trials and regulatory submission strategies. Your role includes collaborating with internal and external stakeholders to ensure the success of the clinical development program.

The ideal candidate will have a PhD in a quantitative field and extensive experience in clinical trials, including interactions with regulatory authorities. The position supports remote work within the U.S. but involves travel to the corporate location in Cambridge, MA.

Qualifications

• 10+ years experience in clinical trials for PhD candidates or 14+ years for MSc graduates.
• Proficiency in advanced statistical analyses and simulations.
• Excellent written and verbal communication skills required.

Responsibilities

• Lead statistical strategies for clinical development plans.
• Oversee CRO statistical activities to ensure quality and compliance.
• Mentor and develop junior statisticians in best practices.

Skills

Statistical leadership

Clinical trial design

Statistical programming (SAS or R)

Regulatory submission experience

Communication and negotiation skills

Education

PhD in Statistics/Biostatistics or related field

MSc with experience

Tools

SAS

R

Job description

Amylyx Pharmaceuticals is seeking a Director of Biostatistics to oversee statistical leadership in clinical trials and regulatory submission strategies. Your role includes collaborating with internal and external stakeholders to ensure the success of the clinical development program.

The ideal candidate will have a PhD in a quantitative field and extensive experience in clinical trials, including interactions with regulatory authorities. The position supports remote work within the U.S. but involves travel to the corporate location in Cambridge, MA.