Senior Biostatistics Manager, Clinical Development

Scholarrock

Cambridge (MA)

On-site

USD 150,000 - 210,000

Full time

5 days ago

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Job summary

Scholar Rock is seeking a Senior Manager/Associate Director of Biostatistics to lead statistical activities across clinical studies from design through regulatory submission. The role requires independent management of multi-study programs (Phase 1–3) and collaboration with cross-functional teams.

Expertise in SAS and R, plus FDA/ICH regulatory experience, is essential. You will develop SAPs, review analyses, oversee CROs, and contribute to regulatory documents and publications, with up to 20%

Qualifications

Doctorate degree in statistics, biostatistics or related field.
Minimum 2 years of relevant drug development experience for Senior Manager; 4 years for Associate Director.
Excellent communication skills and ability to influence cross-functional teams.

Responsibilities

Provide statistical leadership for one or multiple clinical studies from Phase 1 through Phase 3.
Develop or review Statistical Analysis Plans and programming specifications.
Ensure high-quality statistical deliverables and data interpretation.
Oversee external vendors and CROs and support regulatory interactions.
Contribute to publications and regulatory documents.

Skills

Statistical leadership

Independent worker

Cross-functional collaboration

Analytical thinking

Regulatory focus

Education

Doctorate degree in statistics/biostatistics or related field

Tools

SAS programming

R programming

Job description

Expertise in SAS and R, plus FDA/ICH regulatory experience, is essential. You will develop SAPs, review analyses, oversee CROs, and contribute to regulatory documents and publications, with up to 20%

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