Scholar Rock is a biopharmaceutical company that discovers, develops, and delivers life-changing therapies for people with serious diseases that have high unmet need. As a global leader in the biology of the transforming growth factor beta (TGFß) superfamily of cell proteins and named for the visual resemblance of a scholar rock to protein structures, the clinical-stage company is focused on advancing innovative treatments where protein growth factors are fundamental. Over the past decade, the company has created a pipeline with the potential to advance the standard of care for neuromuscular disease, cardiometabolic disorders, cancer, and other conditions where growth factor-targeted drugs can play a transformational role. Scholar Rock is the only company to show clinical proof of concept for a muscle-targeted treatment in spinal muscular atrophy (SMA). This commitment to unlocking fundamentally different therapeutic approaches is powered by broad application of a proprietary platform, which has developed novel monoclonal antibodies to modulate protein growth factors with extraordinary selectivity. By harnessing cutting-edge science in disease spaces that are historically under-addressed through traditional therapies, Scholar Rock works every day to create new possibilities for patients. Learn more about the company's approach at ScholarRock.com and follow @ScholarRock and on LinkedIn. Summary of Position: 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.
\n Position Responsibilities: Provide input to product strategy from a statistical perspectiveLead 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 studyLead 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 dataEnsure study data are presented accurately and interpreted appropriately for Medical Affairs presentations and publicationsPresent data in medical affairs meetings or to health authoritiesAuthor publications to support product Candidate Requirements:Graduate degree in statistics, biostatistics or related fieldExperience in drug development, study design, and data analysis and interpretation.Publication experience and/or experience of presenting at conferences/health authority meetingsUp-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) preferredDemonstration 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
\nScholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.