Statistical Programming Lead
7 days ago
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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