Address
Form of workScholar 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 (TGF) 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 Associate Director, Biostatistics will participate in all biostatistics activities in a clinical development program from clinical design to regulatory submission and manuscript publication based on trial results. Key responsibilities include clinical trial design, statistical analysis, 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, dose-finding clinical studies, mid and late-stage efficacy trials and clinical and pre-clinical pharmacokinetic studies.
- Contribute to regulatory submission. Address statistical questions/comments from regulatory agencies.
- Conduct statistical analysis/modeling across different stage 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 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+(for Ph.D) 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 or R programming
- 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
Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
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