Remote Associate Director, Director of Statistical Programming

Summary

Join a dynamic early-stage company working to create selective medicines for cancer patients as Associate Director / Director, Statistical Programming.

Requirements

• Master’s Degree in statistics, mathematics, computer science, or related scientific/medical field
• 8+ years (director level 12+) of (SAS) statistical programming experience in a clinical trial setting (industry/CRO)
• Advanced SAS programming skills - procedures and options commonly used in clinical trials. reporting, including Macro language, BASE SAS, SAS/STAT, and SAS/GRAPH, validation/QC, experience generating listings, tables, figures
• Hands-on knowledge of CDISC SDTM and ADaM models and transforming raw data into these standards
• In-depth understanding of CDISC standards including SDTM and ADaM models and extensive experience of their implementation in clinical trials
• Familiar with regulatory guidelines (FDA, EMA, ICH) related to clinical trials, statistics and data handling in clinical development setting, and advanced knowledge of submission requirements and standards
• Experience with outsourcing programming activities and overseeing services provided by CROs and contractors
• Advanced understanding of statistical concepts in support of clinical data analysis
• Advanced knowledge of programming standards and processes
• Oncology experience is required
• Skilled at performing quality control checks of SAS code and outputs produced by other Statistical Programmers

Responsibilities

• Function as lead programmer to produce and/or validate tables, listings, figures, and analysis datasets in response to regulatory requests, publication requests, and ad-hoc analyses
• Write specifications to describe programming needs
• Develop/review TFL shells, SDTM and ADaM specifications in collaboration with biostatisticians and other clinical development colleagues
• Work closely with Data Management and Biostatistics to ensure final databases, analyses, and reports are accurate
• Partner with or oversee CROs or Programming vendors to perform the tasks described above
• Ensure the proper collection, management, and documentation of clinical trial data according to regulatory requirements
• Manages project timelines and schedules of specific phases of projects and collaborates with internal personnel and outside customer representatives
• Identify problems and develop global tools that increase the efficiency and capacity of the Statistical Programming group (e.g., macros or graphical user interface applications)