Principal Statistical Programmer

Join Clario’s 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 we offer

• Competitive compensation + shift allowances

• Attractive benefits (security, flexibility, support and well-being)

• Engaging employee programs

• Technology for hybrid working and great onsite facilities

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.

• Create and implement data standards and macros to support cardiac safety deliverables.

• Research and apply new programming techniques to enhance data processing and analysis.

• Generate and interpret compliance checks on CDISC-formatted datasets.

• Support statistical analyses and regulatory requirements through client-facing discussions.

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.

• Lead team strategy meetings and contribute to departmental planning.

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.

• Participate in hiring and contribute to strategic planning for the statistical programming function.

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.

• Provide consultation during sponsor and regulatory teleconferences (FDA, EMEA, PMDA).

What we're looking for

• Ph.D. with5+ yearsof relevant industry experience, M.S. with7+ yearsof relevant industry experience or B.S. with10+ yearsof 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 inclinical trials, preferably within a CRO or pharmaceutical research organization

• Proficiency inSAS programming, including creation, testing, and maintenance of CDISC-compliant datasets (SDTM, ADaM)

• Experience withelectronic submission packagesand regulatory interactions (e.g., FDA)

• Familiarity withclinical protocolsandStatistical Analysis Plans

• Experience withTFL generationis a plus

• Solid understanding of thepharmaceutical drug development process

• Proficient inWindowsandMicrosoft Officeproducts

• Demonstratedleadership experienceand/or training

• Excellentverbal and written communication skills

• Strongorganizationalandanalyticalabilities

• Ability to work bothindependentlyand in ateam setting, with flexibility to adapt to changing priorities

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.