Associate Director / Director, Statistical Programming

The Role:

Reporting to the Senior Director, Statistical Programming, the Associate Director / Director, Statistical Programming will be responsible for implementing statistical analyses using SAS and performing quality review of SAS programs and deliverables for in-house analyses as well as out-sourced programming deliverables. This individual will also perform programming analyses to generate ad-hoc requests for publications and presentations.

This is a remote position that will work closely with Biostatistics, Data Management, Clinical Operations, Regulatory, Global Pharmacovigilance, and other related disciplines, as well as CROs.

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).

Competencies Include:

• Adaptability/Flexibility – The ability to adapt to working effectively within a variety of situations; adapts enthusiastically to organizational change and to changes in job demands.
• Communication and Teamwork – Ability to effectively express ideas in written and oral context; to work co-operatively with others; genuine desire to be a part of a team and contribute to organizational and team goals.
• Problem Solving – Ability to understand a situation or problem by breaking it down into smaller pieces using a systematic approach and to identify patterns and connections between situations that are not obviously related.
• Relationship Building – Builds productive working relationships and effectively communicates across a diverse spectrum of people.
• Organizational and results orientation – Ability to plan and handle multiple responsibilities simultaneously and still meet high quality and timeliness standards under pressure.

Qualifications:

• 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.