Principal Statistical Programmer
- Scholar Rock Inc.
- Full time
- Cambridge, Massachusetts
- Posted: November 24, 2021
Company
Scholar Rock is a clinical-stage biopharmaceutical company focused on the discovery and development of innovative medicines for the treatment of serious diseases in which signaling by protein growth factors plays a fundamental role.
Our most advanced investigational product candidate, apitegromab (SRK-015), a selective inhibitor of the activation of the growth factor myostatin in skeletal muscle, is in development for the treatment of spinal muscular atrophy, or SMA. Following positive results from the TOPAZ Phase 2 trial in patients with Type 2 and Type 3 SMA, we are planning to advance to a Phase 3 trial by year-end. In addition, we are conducting our DRAGON Phase 1 proof-of-concept trial for SRK-181, a selective inhibitor of latent TGFβ1 activation, in patients with locally advanced and metastatic solid tumors.
By combining our deep structural insights with antibody drug discovery, Scholar Rock is creating a pipeline of novel product candidates with the potential to transform the lives of patients suffering from a wide range of serious diseases, including neuromuscular disorders, cancer, and fibrosis.
Summary of Position:
The Principal Programmer will lead in-house statistical programming activities and oversight vendor activities in clinical development. The role will lead to build the efficient statistical computing environment, prepare CDISC complained submission package. Requires deep understanding of data standards (e.g,, CDISC SDTM, ADAM, Define.xml ), as well as ICH and regulatory guidelines on data and reporting standards. Drives the development and continuous improvement of departmental procedures. This role will report to the director of statistical programming.
Principal Statistical Programmer will lead all aspects of in-house statistical programming activities and oversight related activities by vendors in clinical development. In collaboration with cross functional stakeholders, this position also contributes to process optimization and innovation for clinical development. This role will help the company build the capability to get submission ready in statistical programing, and requires deep understanding of data standards (e.g,, CDISC SDTM, ADAM, Define.xml ), as well as ICH and regulatory guidelines on data and reporting standards. This role will assist the head of Biometrics to develop departmental strategies and drives the development and continuous improvement of departmental procedures, training and standards.
Position Responsibilities:
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- Build in-house statistical computing environment through builds macros.
- Meta data driven macros for the efficiency of ADaM and analysis creation.
- Create submission ready data and analysis elements, such as ADaM, TLFs, DEFINE.xml etc.
- Oversight vendors activities to ensure the quality of vendor deliverable, such as SDTM, ADaM and analysis outputs.
- Oversight vendors to ensure the processes are followed.
- Support study team needs as ad-hoc analysis and analysis for publications
- Work other functions in the study team to support other functions programming need, such cross-domain data check, safety monitoring outputs, etc.
- Improve and novate internal processes
Candidate Requirements:
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- Bachelor’s degree is required, Master’s degree in Statistics, Mathematics, Computer Science, Computer Information Systems or Public Health is preferred
- 5+ years of SAS programming experience in pharmaceutical or CRO environments; strong candidate with less years of experience will be considered for appropriate position
- In-depth knowledge of CDISC SDTM, ADaM, Define.xml, CFR 21 Part 11 compliance, ICH and FDA standards.
- Deep understanding of data and system dependencies, validation techniques, and integration of studies for ISS/ISE.
Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.