The Associate Director, Biostatistics will participate in all biostatistics activities in a clinical development program from clinical design to regulatory submission. The Biostatistics function is an integral part of every step of clinical development at Scholar Rock, and the Associate Director of Biostatistics plays a key role at the study level, and potentially at a clinical development program level. Key responsibilities include clinical trial design, statistical analysis development, carrying out modeling and simulation, and overseeing statistical deliverables.

Position Responsibilities:

• • Provide accurate and detailed statistical support for clinical trial design, including but not limited to, phase I health volunteer trials, early dose-finding clinical studies, mid- and late-stage efficacy trials, safety trials, and clinical and pre-clinical pharmacokinetic studies.
  • Conduct statistical analysis/modeling across different stages of development to meet project objectives and to guide further clinical development, including but not limited to comparing different study designs, implementing pre-specified analysis plan or ad-hoc analyses.
  • Develop or review Statistical Analysis Plans, including mock displays for TLFs, programming specifications for analysis datasets.
  • Contribute to the development of randomization schedules and supply management algorithms.
  • Contribute to the development of regulatory documents including clinical protocols, Investigator Brochures, IMPDs, INDs, CTAs, briefing documents, study reports, integrated summaries, etc.
  • Provide oversight of statistical activities when outsourced to external vendors
  • Represent biostatistics in study team and clinical development team meetings.

Candidate Requirements:

• • Doctorate degree in statistics, biostatistics or related field
  • Thorough and up-to-date working knowledge of advanced clinical trial statistical methodology and clinical trial designs
  • 4+ years of experience in the design and analysis of clinical trials in biotech, pharma or research environment
  • NDA/BLA/EMEA filings experience strongly preferred
  • Thorough and up-to-date working knowledge of FDA and ICH regulations and industry standards applicable to the design and analysis of clinical trials.
  • Proficient in SAS programming.
  • Proficient in R programming is strongly preferred
  • Demonstrated 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

Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.