Senior Director, Biostatistics — Lead Clinical Analytics

PTC Therapeutics, Inc; New Jersey; On-site; USD 239,000 - 281,000; Full time

Job summary

PTC Therapeutics, Inc is seeking a Senior Director, Biostatistics to lead statistical strategy for clinical development programs across assigned therapeutic areas. The role oversees study design, data analysis plans, regulatory submissions, and cross-functional collaboration with internal and external partners.

The position requires an advanced statistics degree and at least 12 years of industry experience, with strong communication and leadership abilities in a fast-paced environment.

Qualifications

• Advanced degree in Statistics or related field; minimum 12 years progressive statistical experience in pharma/biotech/CRO.
• Hands-on experience supporting clinical studies and interaction with regulatory agencies.
• Strong understanding of advanced statistical theory and its pharmaceutical applications.

Responsibilities

• Ensure timeliness and quality of statistical deliverables for trials, analyses, publications and promotional materials.
• Develop solutions to statistical issues for clinical, regulatory and commercial teams; communicate across functions.
• Collaborate on protocol development, including study design, endpoints, power and sample size assessment.
• Author and implement SAPs and integrated summaries for regulatory submissions.

Skills

Advanced statistics

Clinical study support

Regulatory interaction

Communication skills

Independent work

Education

Advanced degree in Statistics

Job description

PTC Therapeutics, Inc is seeking a Senior Director, Biostatistics to lead statistical strategy for clinical development programs across assigned therapeutic areas. The role oversees study design, data analysis plans, regulatory submissions, and cross-functional collaboration with internal and external partners.

The position requires an advanced statistics degree and at least 12 years of industry experience, with strong communication and leadership abilities in a fast-paced environment.