Proclinical Staffing

Compensation

Full Description

(Associate) Director, Statistical Programming – Permanent – San Francisco Bay Area Proclinical is seeking an (Associate) Director, Statistical Programming for a rapidly growing biotechnology company based in the San Francisco Bay Area. Primary Responsibilities: In this role, you will be responsible for the planning, execution, and quality of SAS programming to conduct statistical analyses in support of clinical trial results. This role is also responsible for submission readiness of study data packages per CDISC standards and FDA guidance, and enhancements of the statistical programming infrastructure of the Biometrics department. The position is based in the San Francisco Bay Area at the company’s HQ in a hybrid work schedule. Skills & Requirements: • Sc/B.A. in Science, Statistics, Mathematics, Computer Science, Engineering, or related field (MS preferred) • 10+ years of experience in clinical trial development (late stage preferred) • FDA/EMEA submission experience a plus • Demonstrated ability for project management of statistical programming projects in clinical development • Experience managing delivery of statistical programming projects by CROs • Ability to navigate uncertainty with creative problem solving and take a hands-on, “roll up your sleeves” approach • In-depth knowledge of SAS BASE, MACRO, STAT, GRAPH, ACCESS • In-depth knowledge of CDISC SDTM and ADaM specifications and associated regulatory guidances • In-depth knowledge of Pinnacle 21 and how to address errors, warnings to generate acceptable reviewer’s guides (SDRG, ADRG) • Knowledge of clinical trial design, data collection, endpoints, statistical methods and standard data summary displays used in oncology and endocrine therapeutic areas preferred The (Associate) Director, Statistical Programming will: • Work with data management to review CRO generated case report forms, database specifications, and data transfer specifications • Review Statistical Analysis Plan, develop specifications, write and execute SAS programs for study data analysis and preparation for clinical study report • Develop specifications, build and execute SAS programs for internal data reviews, publications, exploratory, post-hoc and regulatory review • Develop SAS macros and tools for repeated program use for exploratory and post-hoc analyses • Manage on-time and quality delivery of CRO-generated analyses results • Review & provide feedback on CRO generated Statistical Analyses Plans and SDTM and ADaM specifications for domain and analysis dataset development, CDISC compliance and output displays If you are having difficulty in applying or if you have any questions, please contact Phu Huynh at (+1) 646-779-7961 or p.huynh@proclinical.com. Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies. Proclinical Staffing is an equal opportunity employer.