The Role:

Reporting to the Senior Director, Statistical Programming, the Associate 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 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.