Senior Director, Biostatistics

PTC Therapeutics seeks a Senior Director of Biostatistics to lead clinical trial design and statistical analysis for rare disease therapeutic programs. The role requires providing technical oversight of clinical development initiatives, regulatory submissions, and cross-functional collaboration within a biopharmaceutical organization.

Responsibilities

• Ensure timeliness and quality of statistical deliverables for clinical trials and regulatory submissions
• Develop statistical solutions for clinical, regulatory, and commercial teams across therapeutic areas
• Author and manage statistical analysis plans and study reports for regulatory filings
• Collaborate on protocol development including study design and power analysis
• Support vendor evaluation and management for biostatistics functions

Requirements

• Advanced degree in Statistics or related statistical discipline
• Minimum 12 years of progressive statistical experience in pharmaceutical, biotech, or CRO settings
• Hands-on clinical trial support and regulatory agency interaction experience
• Advanced statistical theory knowledge and pharmaceutical industry application expertise
• Prior BLA, NDA, or MAA submission experience highly desirable
• Ability to influence cross-functionally without direct authority
• Strong verbal and written communication skills

Compensation: $238,700 - $280,800 base salary