Scholar Rock is delivering muscle-targeted breakthroughs to transform the treatment of spinal muscular atrophy (SMA) and other rare neuromuscular diseases where muscle atrophy remains a critical unmet need.
As a global leader in myostatin biology, a field focused on proteins that regulate muscle mass, the biopharmaceutical company is named for the visual resemblance of a scholar rock to protein structures. Our commitment to unlock fundamentally different treatment approaches is powered by broad application of a proprietary platform, which has developed novel monoclonal antibodies to modulate protein growth factors with extraordinary selectivity. Scholar Rock works every day to create new possibilities for patients through its highly innovative anti-myostatin program, including opportunities in additional rare neuromuscular diseases. Learn more about our neuromuscular franchise at ScholarRock.com and follow @ScholarRock on X and on LinkedIn.
Scholar Rock is seeking a motivated, energetic, and outstanding individual with experience in clinical statistics to join our team. The Senior Manager/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 Senior Manager/Associate Director, Biostatistics plays a key role at the study level, and potentially at a clinical development program level. Key responsibilities include day-to-day clinical statistician activities, clinical trial design, statistical analysis development, carrying out modeling, simulation and analysis, and leading statistical deliverables.
Position Responsibilities
- Provide statistical leadership for one or multiple clinical studies from Phase 1 through Phase 3.
- Provide accurate and detailed statistical support for clinical trial design, including but not limited to, phase 1 healthy 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 guide further clinical development, including but not limited to, comparing different study designs and implementing pre-specified analysis plan or ad-hoc analyses.
- Develop or review Statistical Analysis Plans, including mock displays for TFLs, programming specifications for analysis datasets.
- Ensure high-quality statistical deliverables, including statistical outputs, and lead the data interpretation.
- Represent biostatistics in study team and clinical development team meetings, lead the statistical discussion.
- Contribute to the development of randomization schedules and supply management algorithms.
- Author statistical sections and contribute to the development of regulatory documents including clinical protocols, study reports, Investigator Brochures, INDs, briefing documents/package, integrated summaries, etc.
- Support regulatory interactions with agencies.
- Provide oversight of statistical activities when outsourced to external vendors
- Contribute to publications, scientific presentations
Candidate Requirements
- Doctorate degree in statistics, biostatistics or related field. A minimal of 2 years of relevant drug development experience in biotech or pharmaceutical companies for Senior Manager, or a minimum of 4 years for Associate Director
- Ability to work independently, manage multiple programs/studies, remain highly organized and outcome-oriented, demonstrate self-motivation, and adapt in a fast-paced, growing environment
- Strong analytical thinking and strategic problem-solving skills.
- Sound decision-making skills and the ability to navigate complex business and scientific challenges
- Excellent communication skills in writing and in interactions with colleagues, including the ability to clearly describe advanced/complex statistical concepts and interpret results.
- Ability to influence cross-functional teams in a matrixed, global organization
- Thorough and up-to-date working knowledge of statistical methodologies and clinical trial designs, with the ability to propose and implement novel approaches to accelerate clinical development and address challenges in rare disease settings.
- Thorough and up-to-date working knowledge of FDA and ICH regulations and industry standards includes but not limited to applicable to the design and analysis of clinical trials.
- Experience NDA/BLA/EMEA filings experience is strongly preferred
- Proficient in SAS programming.
- Proficient in R programming is strongly preferred
- Experience managing CROs and external vendors is preferred
- Ability to accommodate up to 20% travel or as business needs dictate
Scholar Rock Cambridge, Massachusetts, USA Office
301 Binney St, , Cambridge, Massachusetts , United States, 02142
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