Associate Director of Statistical Programming / Associate Directoress of Statistical Programming

Position Purpose

The Associate Director of Statistical Programming will provide leadership and expertise in the development and maintenance of CSL’s statistical programming capabilities, essential for meeting regulatory obligations. You will collaborate closely with the Director of Statistical Programming to ensure all assigned tasks are managed efficiently through to completion. This role involves working alongside Statisticians to guarantee that deliverables from internal resources or external providers (CROs, FSP providers) are accurate and adhere to CSL standards.

This individual may oversee a Therapeutic Area (TA) or multiple programs within or between TAs, partnering with the Statistics TA lead to ensure all work required in the TA is completed timely and maintains a high standard of quality.

Main Responsibilities and Accountabilities

• Collaborate with the Director of Programming to assess upcoming activities and resource needs, ensuring high quality and timely delivery of assigned projects, with a focus on realistic project planning.
• Oversee the delivery from CROs or manage in-house programming of datasets, outputs, and Data Definition Tables (DDT) for clinical trials and integrated analysis.
• Design and implement complex specifications and programs to analyze and report intricate clinical trial data in CDISC format.
• Coordinate the oversight or in-house programming of exploratory analyses and analyses to support secondary publications or respond to regulatory requests.
• Mentor programmers assigned to projects, providing constructive feedback to their managers as needed.
• As a project or program leader, ensure compliance with programming processes and strategies for accurate and timely programming delivery.
• Test and implement cutting-edge programming methods and tools within the organization, driving automation of delivery, including the use of AI.

Education

BSc in Computer Science, Mathematics, Statistics, or a related field with relevant experience. Other degrees and certifications will be considered if they provide equivalent programming experience.

Experience

• Minimum of 9 years in clinical and/or statistical programming within the CRO/pharmaceutical sector, utilizing SAS Software.
• Thorough understanding of clinical programming and/or statistical programming processes and standards.
• Advanced experience with statistical programming in SAS, including the development and use of SAS Macros.
• In-depth knowledge of CDISC standards (CDASH, SDTM, ADaM).
• Proven ability to work effectively both independently and as part of a team, managing timelines to meet set goals.
• Experience in cross-functional, multicultural, and international clinical trial teams.

Competencies

• Proficient in SAS coding, including SAS macro language.
• Interest and/or experience in diversifying programming tools beyond SAS.
• Experience or passion for automating routine programming tasks.
• Broad knowledge of clinical development processes.
• Strong interpersonal and communication skills, comfortable engaging with senior management.
• A collaborative mindset in a matrix environment.
• Solution-oriented approach and fluency in technical requirements for CDISC compatible datasets and DDT files.
• Experience presenting programming techniques at professional conferences is a plus.

About CSL Vifor

CSL Vifor is a global leader in iron deficiency and nephrology therapies, specializing in strategic global partnerships, in-licensing, development, manufacturing, and marketing of pharmaceutical products aimed at precision healthcare. Our mission is to help patients globally lead healthier lives. Headquartered in St. Gallen, Switzerland, CSL Vifor also includes the joint venture Vifor Fresenius Medical Care Renal Pharma (with Fresenius Medical Care). Our parent company, CSL, is based in Melbourne, Australia, employing 32,000 people and delivering lifesaving therapies to more than 100 countries.

For more information about CSL, CSL Behring, CSL Seqirus, and CSL Vifor, please visit CSL and CSL Plasma.

Our Benefits

For information on CSL benefits, please visit How CSL Supports Your Well-being.

You Belong at CSL

At CSL, Inclusion and Belonging are at the heart of our mission. We celebrate diversity, fostering a culture of curiosity and empathy, enabling us to connect better with our patients and stakeholders. To learn more about our approach to inclusion and belonging, please visit here.

Equal Opportunity Employer

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need accommodation during any part of the application process, please visit our accessibility statement here.

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