Statistical Programming Lead

7 days ago


San Diego, California, United States Xencor Full time

Xencor is a clinical-stage biopharmaceutical company located in the Los Angeles area and San Diego, focused on developing high-potential therapeutics for patients with cancer and other serious diseases.

Job Summary:

This position will be based out of our San Diego office and require hybrid work arrangement. We are seeking a Manager, Statistical Programming, to lead statistical analysis and reporting of data from clinical studies.

Responsibilities:
  • Oversee CRO full-service vendor performance
  • Partner with cross-functional study teams to ensure delivery of results for the Xencor portfolio
  • Attend multi-disciplinary team meetings, representing the programming function
  • Create or review and approve programming plans at study and project levels
  • Provide input on key study-related documents produced by other functions (e.g., CRFs, Data Management Plan, Analytics, SAPs, etc.)
  • Communicate effectively with stakeholders, translating concepts and requirements into technical specifications and providing sensible programming solutions
  • Provide input to specifications to ensure that statistical programming elements are in line with the overall deliverable and adhere to ICH guidelines, Good Clinical Practices, and regulatory requirements
  • Provide hands-on programming and validation support for statistical programming tasks required for various deliverables such as CSR, DSUR, IB, Publications, etc.
  • Work effectively with external vendors to ensure timely delivery of quality products and provide feedback via Acceptance testing of datasets, TLFs etc.
  • Create or review and approve CDISC-compliant deliverables including annotated CRFs, datasets and corresponding documentation for electronic submission to regulatory agencies
  • Develop software systems to generate and/or validate displays of clinical study data as tables, listings, and graphs for electronic submission to regulatory agencies
  • Write, modify, and maintain programs that produce diagnostics and listings for data review in support of Data Management
  • Carry out electronic data transfer (both incoming and outgoing), including support for sample reconciliation
  • Develop and review programs to ensure the data transfer has been produced to specification
  • Assist in developing standards related to statistical programming
  • Assist the team in planning and developing data monitoring tools such as visual analytics, patient profiles, programming checks etc.
  • Create and document archives of software, outputs, and analysis files
  • Review draft clinical reports, journal articles, slide presentations, and other documents to assure that results are reported accurately
  • Support Statistical Programming leadership to achieve corporate and department objectives
  • Provide time and resource estimates for project planning
  • Adhere to all department and company-wide policies regarding conduct, performance, and procedures

The ideal candidate will have a Bachelor's degree in Biostatistics, Statistics, or a related quantitative discipline; Master's degree preferred, and at least 6 years of statistical programming experience in the Pharmaceutical, Biotechnology, or Contract Research Industry.

A competitive salary range is $137,250 to $162,350 depending on qualifications, skills, competencies, education, and experience.

What We Offer:
  • 401k match
  • Healthcare coverage
  • ESPP
  • Broad range of other benefits
  • Annual bonus
  • Equity grant

Xencor requires all employees to be fully vaccinated against COVID-19 as a condition of employment.



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