Scholar Rock is a clinical-stage biopharmaceutical company focused on creating a robust pipeline of product candidates with the potential to transform the lives of patients suffering from a wide range of serious diseases, including neuromuscular disorders, cancer, fibrosis and anemia. Our proprietary platform is built upon newly elucidated understanding of the molecular mechanisms of growth factor activation, which has led to the discovery and development of monoclonal antibodies that locally and selectively target these signaling proteins at the cellular level.
Our lead product candidate, SRK-015, is a highly specific inhibitor of myostatin activation and is currently being evaluated in a Phase 2 proof-of-concept trial for the treatment of patients with Type 2 and Type 3 Spinal Muscular Atrophy (SMA). SRK-015 has received Orphan Drug Designation in both the US and EU.
We are also advancing SRK-181, a highly specific inhibitor of TGFβ1 activation, into clinical development with plans to initiate a Phase 1 trial in patients with solid tumors in mid-2020. We believe SRK-181 has the potential to treat tumors resistant to checkpoint blockade therapy, such as anti-PD(L)1 antibodies.
Summary of Position:
Scholar Rock is looking for a rock star Principal Statistician to serve as Head of Biometrics for this growing organization. The right individual for this role will be responsible for devising and implementing methodological and statistical strategies for Scholar Rock clinical programs in rare disease, immuno-oncology and other therapeutic indications. This position provides an opportunity to build and develop a team of professionals to support the generation and analysis of data to advance the science and bring medicines to patients in need.
- Provide accurate and detailed statistical support for clinical trial design, including but not limited to, early dose-finding clinical studies, mid and late stage efficacy trials and clinical and pre-clinical pharmacokinetic studies.
- Devise and perform innovative statistical approaches to trial design and analytic methodologies
- Develop programs and models for exploratory and sensitivity analyses
- Contribute to the development of regulatory documents including clinical protocols, Investigator Brochures, IMPDs, INDs, CTAs, briefing documents, study reports, integrated summaries, etc.
- Analyze incoming clinical and pre-clinical data to meet project objectives and to guide further clinical development
- Write and review Statistical Analysis Plans, including mock displays for TLFs
- Create or review programming specifications for analysis datasets and TLFs
- Contribute to the development of Randomization schedules and supply management algorithmsand supply management algorithms
- Develop SOPs/ Work Instructions for data management, programming and statistical processes
- Provide technical oversight of data management and statistical activities of external vendors, including but not limited to, overseeing the quality and accuracy of clinical database builds, all interim and final statistical deliverables and the generation of submission-ready datasets
- Undertake Line Management responsibilities for assigned team members
- Represent Biostatistics in meetings and communications with Regulatory Authorities
- Ph.D. in statistics, biostatistics or related field
- Thorough and up-to-date working knowledge of advanced clinical trial statistical methodology and clinical trial designs
- 10+ years of experience in the design and analysis of clinical trials in biotech, pharma and/or CRO environment
- Demonstrated success as statistician supporting NDA/BLA/EMEA filings
- Thorough and up-to-date working knowledge of FDA and ICH regulations and industry standards applicable to the design and analysis of clinical trials
- Thorough and up-to-date working knowledge of SAS and software products and technologies used in conjunction with SAS (e.g. Microsoft Office)
- Thorough and up-to-date working knowledge of industry data standards such as CDASH, SDTM/ ADaM
- Proven success in oversight/ management of data management and biostatistical services provided by CROs
- Experience in representing biostatistics in meetings with regulatory authorities including the FDA and European Authorities
- 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