Job Title: Principal Statistical Programmer
San Diego, CA
Reports to: Director, Statistical Programming
This position will work closely with the Director of Statistical Programming and other members of the Biometrics team to provide programming support across all programs. The ideal candidate will provide hands-on programming and validation support to project teams and oversee external vendors to ensure timely and accurate deliverable. This role will provide technical expertise to the development of programming standards and procedures.
• Program analysis datasets, statistical tables, figures, listings, Integrated Summaries of Safety (ISS), Integrated Summaries of Efficacy (ISE), DSUR, PSUR, IB, progress reports, electronic submissions and other internal and external requests (e.g., publications, responses to regulatory questions).
• Generate SDTM data sets, ADaM data sets, and Define.xml files along with all supporting documentation.
• Provide statistical programming and validation support for clinical study reports, oversee external vendors (e.g., CROs), and help coordinate programming activities with Biometrics lead and other study programmers to meet timelines.
• Develop and/or review SAPs, case report forms, clinical DB specifications, validation plans, TLFs, reporting and analysis datasets specifications, and supporting documentation.
• Ensure quality of project programming deliverables.
• Provide input on programming-related SOPs, work practice documents, technical standards, and programming specification documents.
• Provide input on programming methodologies to support the clinical development process.
• Minimum of Bachelor’s degree in Statistics, Computer Science, Mathematics, or a related technical discipline. Masters preferred. Equivalent combination of education and applicable job experience may be considered.
• Minimum 5 years’ experience in clinical research, ideally as a SAS programming for phase I-IV clinical trials in a pharmaceutical/CRO environment. Lead Programmer experience is required.
• Technical knowledge and experience with SDTM, ADaM, and Define.XML.
• Strong understanding of the drug development process, submission-related activities and regulatory requirements (eg, CDISC, CDASH, eCTD) and guidelines (eg, ICH, CHMP, FDA, GCP).
• Submission support with compliance experience.
• Thorough knowledge of SAS functionalities (including ODS, SQL, MACRO, STAT, GRAPH, and ACCESS) and experience with MS Office are required. Familiarity or experience with R Software is a plus.
• Proven experience with UNIX and Windows operating systems.
• Understanding of the software development life cycle.
• Ability to effectively communicate and perform in a high demand and dynamic working environment.