Director, Biostatistics

Summary

Join Scholar Rock, a biopharmaceutical company focused on developing life-changing therapies, as the Director, Medical Affairs Biostatistics. In this role, you will be the lead statistician for Medical Affairs activities, playing a key role in clinical development from study design to interpretation of results. Key responsibilities include leading study design, statistical analysis, and interactions with health agencies. You will oversee statistical deliverables and ensure accurate data presentation. This position requires a graduate degree in statistics or a related field, experience in drug development, and excellent communication skills. Scholar Rock is an Equal Opportunity Employer committed to creating an inclusive environment.

Requirements

• Graduate degree in statistics, biostatistics or related field
• Experience in drug development, study design, and data analysis and interpretation
• Publication experience and/or experience of presenting at conferences/health authority meetings
• Up-to-date knowledge of advanced statistical methodology for indirect comparison between studies (e.g., network meta-analysis, synthetic control arm, Bayesian borrowing from historical data, causal inference)
• Demonstration of excellent communication skills in writing and in interactions with colleagues, including the ability to clearly describe advanced statistical concepts and interpret results
• Highly organized, outcome-oriented, self-motivated performance
• Ability to adapt to change in a growth environment

Responsibilities

• Provide input to product strategy from a statistical perspective
• Lead study design, development of protocol and statistical analysis plan for Medical Affairs studies, which may include, but are not limited to, EAP studies, real-world studies, and non-interventional qualitative study
• Lead the execution of Medical Affairs studies from a statistical perspective, including overseeing vendors
• Coordinate statistical activities with other members of the Biometrics department, including post hoc analysis of clinical trial data
• Ensure study data are presented accurately and interpreted appropriately for Medical Affairs presentations and publications
• Present data in medical affairs meetings or to health authorities
• Author publications to support product

Preferred Qualifications

Experience in regulatory submission in key markets (US, EU)