Associate Director, Statistical Programming

uniQure•Lexington, KY

9d•Hybrid

About The Position

uniQure Inc. is seeking an Associate Director, Statistical Programming for their Lexington, MA location. This hybrid role is responsible for leading statistical programming activities, including hands-on implementation of statistical analyses using SAS, and quality reviews of SAS programs and deliverables. The position involves both in-house analyses and outsourced programming tasks. The Associate Director will serve as the lead statistical programmer to analyze and interpret statistical data, evaluate statistical modeling and designs, and produce tables, listings, figures, and analysis datasets for various needs. They will also lead the Statistical Programming group, develop and manage the statistical computing environment, and collaborate with biostatisticians and clinical development colleagues on statistical methodology and data standards. The role includes overseeing programming deliverable timelines, managing CROs and contractors, and identifying opportunities to enhance group efficiency through global tools. The Associate Director will act as a subject matter expert (SME) in multi-functional project teams.

Requirements

Master's degree in Statistics, Mathematics, Computer Science or closely related scientific/medical field.
7 years of professional experience in SAS statistical programming in clinical trial settings (industry/CRO).
Advanced SAS programming skills including: Utilizing procedures and options commonly used in clinical trials, Reporting with Macro language, BASE SAS, SAS/STAT, and SAS/GRAPH, validation/QC, and generating listings, tables, figures.
Working with CDISC standards including SDTM and ADaM models and implementing these standards/models in clinical trials.
Working with regulatory guidelines (FDA, EMA, ICH) relevant to clinical trials, statistics, and data handling, preparing data for submission in compliance with regulatory requirements and standards.
Outsourcing programming activities and overseeing services provided by CROs and contractors.
Planning and managing multiple responsibilities concurrently, while maintaining high standards of quality and meeting deadlines.

Responsibilities

Serve as the lead statistical programmer to analyze and interpret statistical data, evaluate statistical modeling and designs, produce and/or validate tables, listings, figures, and analysis datasets for regulatory requests, publication needs, and ad-hoc analyses.
Write specifications for programming requirements.
Lead the Statistical Programming group within the Biometrics Department to ensure proper data structuring, data collection and tabulation.
Develop and manage the statistical computing environment, including statistical folder structure and access control.
Collaborate with biostatisticians and clinical development colleagues to evaluate statistical methodology, develop/review Tables, Figures, and List (TFL) shells, Study Data Tabulation Models (SDTMs), and Analysis Data Model (ADaM) specifications.
Oversee study-level programming deliverable timelines in collaboration with the study lead biostatistician and cross-functional teams and adapt statistical methods to solve problems efficiently within projected timelines.
Manage Contract Research Organizations (CROs) and contractors, ensuring compliance, quality of deliverables, timelines, and budget adherence.
Work closely with Data Management and Biostatistics teams to ensure the accuracy of final databases, analyses, and reports.
Identify issues and develop global tools, such as macros or graphical user interface applications, to enhance the efficiency and capacity of the Statistical Programming group.
Liaise between the biostatistics and clinical data management group to ensure the delivery of high-quality clinical data.
Serve as subject matter expert (SME) in multi-functional project teams, providing strategic and technical expertise.