Senior Biostatistics Lead — Clinical Trials & Analytics

PTC Therapeutics, Inc; Warren Township (NJ); On-site; USD 148,000 - 180,000; Full time

Benefits offered by this job

Incentives

Medical/Dental/Vision

Retirement plans

Job summary

PTC Therapeutics, Inc. is seeking a Senior Manager, Biostatistics to lead the statistical design and analysis for clinical development programs and trials.

You will interact with regulatory agencies and guide endpoints, analysis plans, and interpretation of results. The role requires advanced statistical training (PhD or MSc) and substantial experience in pharmaceutical settings, with strong cross-functional collaboration and communication skills.

Qualifications

• PhD in Statistics or related discipline with 6+ years pharma/CRO experience
• Master's in Statistics or related discipline with 8+ years experience in similar settings
• Hands-on statistical programming with SAS and/or R
• Strong communication and collaboration across cross-functional teams

Responsibilities

• Ensure timely and high quality statistical deliverables for clinical trial results, analyses, publications and promotions
• Develop statistical solutions for clinical, regulatory, and commercial teams and communicate them cross-functionally
• Participate in vendor evaluation, selection, and management
• Collaborate on protocol development including study design, endpoints, power and sample size
• Review CRFs and edit checks to ensure proper data capture
• Author and manage statistical analysis plans and study reports
• Support submissions and regulatory interactions as needed

Job description

PTC Therapeutics, Inc. is seeking a Senior Manager, Biostatistics to lead the statistical design and analysis for clinical development programs and trials.

You will interact with regulatory agencies and guide endpoints, analysis plans, and interpretation of results. The role requires advanced statistical training (PhD or MSc) and substantial experience in pharmaceutical settings, with strong cross-functional collaboration and communication skills.