Proclinical Staffing ยท 3 weeks ago
(Associate) Director, Statistical Programming
San Francisco Bay Area
Full-time
Hybrid
Director/Executive
10+ years expProclinical is seeking an (Associate) Director, Statistical Programming for a rapidly growing biotechnology company based in the San Francisco Bay Area. This role is responsible for the planning, execution, and quality of SAS programming to conduct statistical analyses in support of clinical trial results, as well as ensuring submission readiness of study data packages per CDISC standards and FDA guidance.
Staffing & Recruiting
Hiring Manager
Phu Huynh
Responsibilities
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
Qualification
Required
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)
Preferred
Knowledge of clinical trial design, data collection, endpoints, statistical methods and standard data summary displays used in oncology and endocrine therapeutic areas preferred
Company
Proclinical Staffing
At Proclinical Staffing, our life science recruitment services support our partners with permanent and contract vacancies by connecting them with specialist talent across the globe.
51-200 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase