Senior Manager, Statistical Programming
Clinical | San Carlos, CA | Full Time
ChemoCentryx is searching for a Senior Manager – Statistical Programming that will support our exciting portfolio of experimental and commercialized drugs. They will report to the Executive Director – Biostatics and will work out of our corporate center in San Carlos, CA.
The Sr. Manager will work with biostatistics and data management groups to complete the Statistical Programming deliverables for multiple clinical studies or therapeutic areas by ensuring internal consistency of output. Assess consistency with other activities for the project as applicable while also ensuring accuracy of database quality assurance checks and assess data accuracy and consistency.
Essential Duties and Responsibilities:
- Technical lead and project manager for multiple studies managing all aspects of study deliverables related to statistical and clinical programming
- Support the programming for Clinical Study Report (CSR), Integrated Summaries of Safety (ISS), Integrated Summaries of Efficacy (ISE) submissions and various other submissions during conduct of clinical trials
- Generate/review the CDISC SDTM and ADaM files and specifications, SAS export files and Define.xml use for Electronic Submission provided by CROs
- Reviews Data Management Plan, Data validation plan and edit check specifications Interacts with biostatisticians and other clinical team members, perform ad hoc analysis and generate outputs according to the requirements
- Interact and communicate with Biostatisticians, Data Managers, Clinical Development, Clinical Operations, Medical Monitors, Drug Safety, Medical Writing, Clinical Pharmacology, etc. to define programming related study deliverables
- Develop, test, validate and execute product- and study-level macros and utilities
- Interface with outsourcing partners and vendor
- Bachelor’s degree and 5+ years Pharmaceutical/Biotech programming experiences OR a Master’s degree, in Statistics, Mathematics
- Expert level knowledge and extensive hands-on experience of CDISC methodologies,
- Expert level experience of writing CDSIC standard dataset specifications and follow specifications to create SDTM and ADAM datasets
- Expert level SAS programming and management background along with Solid knowledge and experience of SAS Programming language including SAS Base, SAS/Macros, SAS/Graph and SAS/Stat
- Experience leading or working with centralized teams for Statistical Programming
- Experience with the drug development process
ChemoCentryx is a biopharmaceutical company focused on discovering, developing, and commercializing novel therapeutics to treat autoimmune diseases, inflammatory disorders and cancer, primarily focused on orphan and rare diseases. ChemoCentryx balances a passion for science with the deep-seated belief that patients suffering from serious diseases deserve more than incremental improvements to the length and quality of their lives.
At ChemoCentryx, our salary and benefits packages are among the most competitive in the industry. All our employees share the rewards of their work through a generous stock option program. We also offer 401K and Flexible Spending Accounts. ChemoCentryx employees enjoy a comprehensive benefits package including medical, dental and vision coverage as well as life insurance, and short and long-term disability insurance.