The Director, Statistical Programming provides leadership and expertise in developing and maintaining CSL's statistical programming capabilities to meet regulatory obligations. This role manages a team of programmers supporting clinical trial and integrated analyses, annual reporting, regulatory responses, publications, HTA requests, and other needs within one or more therapeutic areas. The individual works closely with the Senior Director, Clinical and Statistical Programming to advance the internal programming environment and statistical programming processes, and collaborates with Statisticians to ensure deliverables from internal resources or external providers are accurate and aligned with CSL standards.
Tasks
- Work with the Biometrics Programming Leadership team to assess upcoming activities, determine resource needs, and allocate projects to ensure high quality and timely delivery.
- Ensure realistic resource planning.
- Oversee CRO delivery or manage in-house programming of data sets, outputs, and DDT files for clinical trials and integrated analysis.
- Coordinate oversight or in-house programming of exploratory analyses, analyses to support secondary publications, responses to regulatory requests, or other ad-hoc requests.
- Manage, hire, and mentor direct reports, including conducting annual evaluations and goal setting.
- Create, maintain, and ensure compliance with programming processes and strategy as a member of the programming leadership team within biometrics.
- Help introduce state-of-the-art programming methods and tools to the organization and drive automation of delivery, including AI.
- Collaborate with Biometrics and other departments to ensure efficient and high-quality process transition points.
- Represent the company in outside professional organizations and meetings.
Requirements
- BSc in Computer Science, Mathematics, Statistics, or related area with relevant experience; other degrees and certifications considered if commensurate with related programming experience.
- At least 10 years of experience in the biotech, pharma, or CRO industries.
- Preferred 5 or more years of direct supervisory experience.
- Experience with CRO management and/or CRO work experience.
- Extensive understanding of clinical programming and/or statistical programming processes and standards.
- Advanced experience with statistical programming using SAS software, including development and use of SAS Macros; preferred experience managing a team performing these activities.
- Advanced knowledge in CDISC standards (CDASH, SDTM, ADaM).
- Proven ability to work effectively both independently and in a team setting, and to meet set goals by managing own timelines.
- Experience working in cross-functional, multicultural, and international clinical trial teams.
- Coding in SAS, including SAS macro language.
- Interest and/or experience in expanding beyond SAS as the primary programming delivery tool.
- Experience in and passion for automation 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 and provide leadership 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.
Benefits
- The expected base salary range for this position at hiring is $239,000 - $308,000 at the Waltham, MA location.
- Total compensation may include incentive compensation and equity.
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