Senior Biostatistics Leader - Clinical Trials Strategy

ptcbio; New Jersey; On-site; USD 148,000 - 180,000; Full time

Benefits offered by this job

Short- and long-term incentives

Medical, dental, vision, and 401(k)

Job summary

PTC Therapeutics in New Jersey seeks a Senior Manager, Biostatistics to guide design and analysis for clinical development programs. You will shape study designs, analysis plans, and communicate findings to internal teams and external stakeholders, with possible interactions with regulatory agencies.

You will collaborate across functions to ensure SOP adherence, vendor management, and timely statistical deliverables.

Qualifications

• PhD in Statistics or related discipline with minimum 6 years of statistical experience in pharma/biotech, CRO, or related environment.
• Master's degree in Statistics or related discipline with minimum 8 years of statistical experience in pharma/biotech, CRO, or related environment.
• Hands-on statistical programming using SAS and/or R.
• Excellent understanding of regulatory requirements and guidance documents.

Responsibilities

• Ensures the timeliness and quality of statistical deliverables for clinical trial results, exploratory and meta-analyses, publications activities, and regulatory submissions.
• Develops solutions to statistical and data analysis issues for clinical, regulatory, and commercial teams; communicates solutions cross-functionally.
• Participates in vendor evaluation, selection, and management.
• Collaborates on protocol development including study design, endpoint selection, and power and sample size assessment.
• Reviews CRFs, annotations, and edit checks to ensure data quality for analyses.
• Authors and manages the implementation of statistical analysis plans.
• Authors and reviews statistical and outcome sections of study reports and submissions.
• Performs other tasks as needed by management.

Skills

SAS programming

R programming

Microsoft Office

Communication

Education

PhD in Statistics or related discipline

MSc in Statistics or related discipline

Tools

SAS

R

Job description

PTC Therapeutics in New Jersey seeks a Senior Manager, Biostatistics to guide design and analysis for clinical development programs. You will shape study designs, analysis plans, and communicate findings to internal teams and external stakeholders, with possible interactions with regulatory agencies.

You will collaborate across functions to ensure SOP adherence, vendor management, and timely statistical deliverables.