Associate Director/Director Statistical Programming

Company: Scholar Rock
Location: Cambridge
Posted on: May 26, 2023

Job Description:

Scholar Rock is a Phase 3, 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 now advancing apitegromab development through SAPPHIRE, an ongoing, randomized, double-blind, placebo-controlled, phase 3 clinical trial. In addition, we are conducting our DRAGON Phase 1 proof-of-concept trial for SRK-181, a selective inhibitor of latent TGF--1 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 Associate Director/Director, Statistical Programming will lead the statistical programming activities for clinical trials, conduct statistical analyses, oversight vendor activities, interact with other functions and support various programming needs. The role will lead the effort to support the coming BLA submission, create GxP compliant analysis outputs, prepare CDISC compliance submission package. Requires deep understanding on data standards (e.g., CDISC SDTM, ADAM, ), as well as ICH and regulatory guidelines on data and reporting standards. Contribute to the development and continuous improvement of departmental procedures. This role will report to the Senior Director of Statistical Programming.Position Responsibilities:

• Lead statistical programming activities for study(ies) and ensure timely deliveries
• Create submission ready data and analysis elements, such as ADaM, TLFs, etc.
• Oversight of vendor activities to ensure the quality of vendor deliverable, such as SDTM, ADaM and analysis outputs
• Oversight of vendors to ensure the processes are followed
• Support study team needs as ad-hoc analysis and analysis for publications
• Work cross-functionally across the study team to support other functions programming needs, such as cross-domain data check, safety monitoring outputs, etc.
• Help to improve and innovate internal processesCandidate Requirements:
  • Experienced on leading statistical programming team activities, submission experience is preferred.
  • Good project management and communication skills
  • Bachelor's degree is required, Master's degree in Statistics, Mathematics, Computer Science, Computer Information Systems or Public Health is preferred
  • 10+ years of SAS programming experience in pharmaceutical or CRO environments; strong candidate with less years of experience will be considered for appropriate position
  • Enjoy coding and innovation
  • In-depth knowledge of CDISC SDTM, ADaM, , 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.
  • Thorough knowledge of SAS and working knowledge of different SAS environment (e.g., SAS EG in UNIX and Windows) is requiredScholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

Keywords: Scholar Rock, Cambridge , Associate Director/Director Statistical Programming, Executive , Cambridge, Massachusetts