Associate Director, Statistical Programming (M/F/D)

Job Title: Associate Director, Statistical Programming

The Associate Director, Statistical Programming provides leadership and expertise in driving the development and maintenance of CSL's statistical programming capabilities, essential for meeting regulatory obligations. The individual will collaborate closely with the Director of Statistical Programming to ensure that all assigned statistical programming tasks are managed to completion. This role involves working with statisticians to guarantee that deliverables, whether from internal resources or external partners (CROs; FSP providers), are accurate and aligned with CSL standards.

This individual may manage therapeutic areas (TAs) or programs within or across TAs, working with the Statistics TA lead to ensure that all work required in the TA is completed within project timelines and maintains high quality.

Main Responsibilities and Accountabilities

• Collaborate with the Director, Programming to assess upcoming activities and resource needs, ensuring high-quality, timely delivery of assigned projects and realistic project planning.
• Oversee the delivery from CROs or manage the in-house programming of datasets, outputs, and DDT files for clinical trials and integrated analysis.
• Plan and lead the design and implementation of complex specifications and programs for applications aimed at analyzing and reporting intricate clinical trial data in CDISC format.
• Coordinate the oversight or in-house programming of exploratory analyses and analyses to support secondary publications, responses to regulatory requests, or other ad hoc requests.
• Mentor programmers allocated to assigned projects and provide feedback to their managers as needed.
• As a project or program leader, ensure compliance with programming processes and strategies to support accurate and timely programming.
• Test and implement state-of-the-art programming methods and tools, driving automation of delivery, including AI integration.

Education

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

Experience

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

Competencies

• Proficient coding in SAS, including SAS macro language.
• Interest or experience in expanding programming toolsets beyond SAS.
• Experience and passion for automating routine programming tasks.
• Broad knowledge of clinical development processes.
• Strong interpersonal and communication skills (verbal and written in English), comfortable interacting with senior management.
• Able to collaboratively work in a matrix environment.
• Solutions-oriented mindset.
• Fluency in technical requirements for CDISC-compatible datasets and DDT files.
• Presentations of programming techniques at professional conferences is a plus.

Apply online using the form below. Only applications matching the job profile will be considered.