Associate Director, Statistical Programming (w/m/d)

Leadership and Expertise in Statistical Programming

Provide leadership and expertise in driving the development and maintenance of statistical programming capabilities required to meet regulatory obligations. Work closely with the Director, Statistical Programming to ensure all assigned tasks are managed to completion. Collaborate with Statisticians to ensure that deliverables provided by internal resources or outside providers are accurate and aligned with organizational standards.

Manage Therapeutic Areas or programs within or across TAs, working with the Statistics TA lead to ensure all required work is completed within project timelines with high quality.

Main Responsibilities and Accountabilities

• Work with the Director, Programming to assess upcoming activities and resulting resource needs, ensuring high-quality, timely delivery of assigned projects and realistic project planning.
• Oversee CRO delivery or manage in-house programming of data sets, outputs, and DDT files for clinical trials and integrated analysis.
• Plan and lead the design and implementation of complex specifications and programs for applications designed to analyze and report complex clinical trial data in CDISC format.
• Coordinate the oversight or in-house programming of exploratory analyses, analyses to support secondary publications, responses to regulatory requests, or other ad-hoc requests.
• Mentor programmers allocated to assigned projects and provide feedback to managers of these team members as needed.
• Ensure compliance with programming process and strategy as a project or program leader to facilitate accurate and timely programming.
• Test and implement state-of-the-art programming methods and tools to the organization and drive automation of delivery, including AI.

Education

• BSc in Computer Science, Mathematics, Statistics, or a related area with relevant experience.
• Other degrees and certifications are considered if commensurate with related programming experience.

Experience

• At least 9 years of experience in either clinical programming and/or statistical programming within the CRO/pharmaceutical environment using SAS Software.
• Comprehensive understanding of clinical programming and/or statistical programming processes and standards.
• Advanced experience with statistical programming using SAS software, including the development and use of SAS Macros.
• Advanced knowledge in CDISC standards (CDASH, SDTM, ADaM).
• Proven ability to work effectively both independently or in a team setting, and to meet set goals by managing own timelines.
• Experience in working in cross-functional, multicultural, and international clinical trial teams.

Competencies

• Coding in SAS, including SAS macro language.
• Interest and/or experience in expanding beyond SAS as the primary programming delivery tool.
• Experience in and/or passion for the automatization of routine programming tasks.
• Broad knowledge of clinical development and processes.
• Strong interpersonal and communication skills (verbal and written in English), comfortable around senior management.
• Ability to collaboratively work in a matrix environment.
• A solutions-oriented mindset.
• Fluency in technical requirements for CDISC compatible datasets and DDT files.
• Presentations of programming techniques at professional conferences is a plus.