Biostatistics Lead, Clinical Development (Phase 1-3)

Scholar Rock, Inc.; Cambridge (MA); On-site; USD 155,000 - 225,000; Full time

Job summary

Scholar Rock is seeking a motivated Biostatistics statistician to join its team as Senior Manager/Associate Director, Biostatistics. You will participate in all biostatistics activities from clinical design to regulatory submission, provide statistical leadership across trials, and oversee external vendor activities.

A PhD in statistics/biostatistics or related field is required, with extensive experience in drug development and regulatory filings.

Qualifications

• Doctorate degree in statistics, biostatistics or related field.
• Ability to work independently, manage multiple programs/studies, stay organized and outcome-oriented.
• Strong analytical thinking and strategic problem-solving skills.
• Excellent communication in writing and interaction with colleagues.

Responsibilities

• Provide statistical leadership for clinical studies from Ph 1 to Ph 3.
• Support trial design and statistical analysis development, modeling, simulation and analyses.
• Develop or review Statistical Analysis Plans and Datasets specs.
• Lead statistical deliverables and data interpretation.
• Represent biostatistics in study team and clinical development team meetings.

Skills

Statistical analysis

Problem solving

Cross-functional influence

Communication

Education

PhD in statistics/biostatistics or related field

Tools

SAS

R

Job description

Scholar Rock is seeking a motivated Biostatistics statistician to join its team as Senior Manager/Associate Director, Biostatistics. You will participate in all biostatistics activities from clinical design to regulatory submission, provide statistical leadership across trials, and oversee external vendor activities.

A PhD in statistics/biostatistics or related field is required, with extensive experience in drug development and regulatory filings.