Senior Manager/Associate Director* Biostatistics - REMOTE

Penfield Search Partners; California (MO); Remote; Full time

Job summary

An established industry player is seeking a Senior Manager or Associate Director of Biostatistics to join a clinical-stage biopharmaceutical company focused on Rare Diseases. This role offers a unique opportunity to lead statistical design and analysis for clinical trials across all phases of development. The ideal candidate will have a Ph.D. in Biostatistics or a related field, with strong experience in clinical trials and proficiency in statistical programming. Join a dynamic team making a significant impact in the Rare Disease space and take your career to the next level in this highly visible role.

Qualifications

• Ph.D. required with 4+ years in clinical trials for Senior Manager level.
• Strong knowledge of regulatory requirements and statistical design.

Responsibilities

• Lead statistician for clinical development studies from design to submission.
• Develop statistical analysis plans and contribute to clinical study reports.

Skills

Statistical Programming (SAS, R)

Statistical Experimental Design

Regulatory Submissions

Communication Skills

Education

Ph.D. in Biostatistics, Statistics, Mathematics

MS in related field

Tools

SAS

R

Job description

California, United States

Penfield Search Partners California, United States

1 week ago Be among the first 25 applicants

Get AI-powered advice on this job and more exclusive features.

Penfield Search Partners provided pay range

This range is provided by Penfield Search Partners. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$1.00/yr - $2.00/yr

Direct message the job poster from Penfield Search Partners

Our client, a clinical-stage biopharmaceutical company focused on Rare Diseases, is seeking a Senior Manager or Associate Director of Biostatistics to join their growing team. This is a unique opportunity to serve as the second Statistician in the organization and take on a strategic leadership role in driving statistical design and analysis for clinical trials across all phases of development. *This role can come in at Director level for an exceptional candidate, depending on experience.

Key Responsibilities:

• Serve as the lead statistician on clinical development studies, from protocol design through regulatory submission
• Develop statistical analysis plans, author mock analysis packages (tables, figures, listings), and contribute to clinical study reports
• Partner closely with data management to align CRFs with protocols and SAPs; conduct user acceptance testing (UAT) for clinical trial systems
• Oversee and collaborate with internal or CRO programmers to ensure quality and timely delivery of TFLs
• Contribute to regulatory submissions including eCTDs, briefing documents, and responses to health authority queries
• Stay current with FDA, ICH, and other regulatory statistical guidelines

Qualifications:

• Ph.D. in Biostatistics, Statistics, Mathematics, or a related field
• Minimum of 4 years’ experience in clinical trials within the pharmaceutical or biotech industry (for the Senior Manager level); MS 7+ years
• Strong knowledge of statistical experimental design and regulatory requirements for clinical studies
• Proficiency in statistical programming using SAS and/or R
• Experience with eCTD submissions and direct interactions with regulatory authorities
• Strong communication and interpersonal skills; ability to thrive in a dynamic and evolving environment

This is a highly visible and impactful role with room for growth as the company advances its pipeline. If you're ready to bring your statistical leadership to a company making a difference in the Rare Disease space, we encourage you to apply.

Seniority level

• Director

Employment type

• Full-time

Job function

• Science