Principal Biostatistician — Clinical Statistics Leader

Penfield Search Partners Ltd.; Philadelphia (Philadelphia County); Hybrid; USD 140,000 - 210,000; Full time

Job summary

Penfield Search Partners Ltd. is seeking a Principal Biostatistician to provide statistical leadership for clinical development programs in a global organization focused on rare diseases and diverse therapeutic areas.

The role will drive statistical strategy, design, analysis, and regulatory submissions across multiple programs with CRO collaborations. The candidate will lead collaborations with regulatory authorities, oversee deliverables, and contribute to innovative study designs and

Qualifications

• PhD or MS in Biostatistics with pharma/CRO experience.
• Experience leading statistical contributions at study level.
• Experience with statistical methods for regulatory submissions.

Responsibilities

• Provide input to statistical strategy for clinical trials and regulatory submissions.
• Lead Biostatistics conduct across study design, data collection, analysis, reporting, and submission prep.
• Author the statistical analysis plan for trials and regulatory submissions.
• Ensure timely, high-quality statistical deliverables and analyses.
• Interact with regulatory authorities (FDA/EMA/PMDA) as needed.
• Interpret results and ensure reporting accuracy.

Skills

Biostatistical leadership

Study design

Regulatory submissions

CRO management

Education

PhD in Biostatistics

MS in Biostatistics

Tools

SAS

R

Job description

Penfield Search Partners Ltd. is seeking a Principal Biostatistician to provide statistical leadership for clinical development programs in a global organization focused on rare diseases and diverse therapeutic areas.

The role will drive statistical strategy, design, analysis, and regulatory submissions across multiple programs with CRO collaborations. The candidate will lead collaborations with regulatory authorities, oversee deliverables, and contribute to innovative study designs and