Principal Statistical Programmer

Join Clarios industry-leading Digital Physiology team as a Principal Statistical Programmer, where your expertise will drive innovation in clinical research. This is a unique opportunity to lead advanced statistical programming for cardiac safety trials, shaping the future of digital health through cutting-edge data science and global collaboration.

What you'll be doing

Statistical Programming & Data Standards

• Lead and coordinate all statistical programming activities for cardiac safety trials.
• Develop, test, and maintain SAS code to generate CDISC-compliant datasets (SDTM, ADaM).
• Produce and maintain submission-ready datasets and electronic submission packages (e.g., define.xml, reviewer’s guide) in accordance with FDA guidelines.

Team Leadership & Mentorship

• Manage direct reports in a line or matrix capacity, including work allocation, resource planning, and professional development.
• Conduct onboarding and training on statistical programming practices and SOPs.
• Mentor junior staff and provide guidance on programming methodologies and quality standards.

Process Improvement & Strategic Initiatives

• Identify and implement process improvements to enhance operational efficiency.
• Develop and maintain SOPs, SWIs, templates, and playbooks for programming deliverables.
• Drive initiatives for future analyses, data quality, and standardization.

Cross-functional Collaboration & Project Management

• Collaborate with cross-functional teams to define scope and timelines for statistical deliverables.
• Manage client commitments and ensure timely delivery of assigned projects.
• Maintain accurate tracking of deliverable statuses and dates.

What we're looking for

• Ph.D. with

  5+ years

  of relevant industry experience, M.S. with

  7+ years

  of relevant industry experience or B.S. with

  10+ years

  of relevant industry experience
• A degree in medical, health, public, or general science—or an equivalent combination of education and experience sufficient to perform job duties
• Strong experience in

  clinical trials

  , preferably within a CRO or pharmaceutical research organization
• Proficiency in

  SAS programming

  , including creation, testing, and maintenance of CDISC-compliant datasets (SDTM, ADaM)
• Experience with

  electronic submission packages

  and regulatory interactions (e.g., FDA)
• Familiarity with

  clinical protocols

  and

  Statistical Analysis Plans

• Experience with

  TFL generation

  is a plus
• Solid understanding of the

  pharmaceutical drug development process

At Clario, we put people first, always. We are united and driven by patients, committed to making a difference, and we are always looking for the best talent to help us transform lives. We value the contribution each of our people brings. It’s only through our people that we can continue to innovate technology that will shape the future of clinical trials.