The Director, Medical Affairs Biostatistics, will be the lead statistician for Medical Affairs activities. The Biostatistics function is an integral part of every step of clinical development at Scholar Rock, and Director of Biostatistics plays a key role not only at the study level, but at a development program level. Key responsibilities include study design, statistical analysis development, carrying out modeling and simulation, interacting with health agencies, overseeing statistical deliverables and interpreting the study results.

Position 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

Candidate 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)
  • Experience in regulatory submission in key markets (US, EU) preferred
  • 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