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Associate Director/Director of Statistical Programming

Encoded Therapeutics

Encoded Therapeutics

South San Francisco, CA, USA
Posted on Tuesday, January 23, 2024

Encoded Therapeutics Inc. is a biotechnology company advancing precision medicines for a broad range of genetic disorders. Our mission is to unlock new opportunities for viral gene therapy through genomics-driven discovery. We focus on delivering life-changing advances for individuals with genetic disorders not addressable with current approaches. For more information, please visit www.Encoded.com.

Manages projects, individual contributors (employee and/or contractors), and/or vendors. Actively participates in hands-on programming work and oversight as needed. Builds out department (standards, applications, and processes) and SAS infrastructure (macros and programs) to summarize clinical data in the form of tables, listings, and figures (TLFs). Participates in DB, eCRFs, SAP, CSR, abstracts, and manuscript review as needed. Role will be hands-on initially. Function and department building opportunities will follow as clinical programs mature

Workplace Model: Hybrid

Responsibilities

  • Work with Biostatistics, Data Management, Clinical Operations, Regulatory, Pharmacovigilance and other functions to deliver data deliverables.
  • Develops SAS macros and programs to generate tables, listings, and figures (TLFs) according to the statistical analysis plan (SAP).
  • Create CDISC SDTM and ADaM files, SAS export files, and define.xml for electronic submissions.
  • Draft analysis dataset specifications.
  • Review deliverables for accuracy (e.g., TLFs for study reports, submission documents, publications, meeting presentations, and ad-hoc requests).
  • Manage programming activities and oversee CROs as needed.
  • Generate ad-hoc analyses.
  • Create and maintain SOPs related to statistical programming and ensure processes are consistently followed.
  • Provide input on study-related documents generated within the biometrics team (e.g. CRFs, SAP, DMP, DVP, and edit check specifications, etc.).
  • Provide time and resource estimates for project planning.
  • Participate in Human Resources activities for the department (staffing, performance management and employee development).
  • Buildout statistical programming team.