Provides technical leadership for clinical programming activities supporting the development and delivery of high-quality clinical trial data and reporting solutions. Serves as a subject matter expert in clinical programming, driving standards, innovation, and operational excellence across studies and programs. Partners cross-functionally with Clinical Data Management, Biostatistics, Clinical Operations, and external vendors to ensure compliant, efficient, and scalable programming solutions that support regulatory and business objectives. Leads complex initiatives through expertise, influence, and strategic problem-solving.
Key Accountabilities / Core Job Responsibilities- Lead the design, development, validation, and maintenance of SAS and R programming solutions supporting clinical study and program deliverables.
- Serve as the clinical programming lead for complex studies and programs, ensuring timely, high-quality delivery of outputs that meet regulatory and business requirements.
- Establish, maintain, and advance programming standards, reusable code libraries, and validation frameworks to improve consistency, quality, and efficiency.
- Develop innovative solutions for complex data transformations, custom listings, data integrations, and reporting requirements.
- Provide technical mentorship, code review, and subject matter expertise to programming colleagues and cross-functional partners.
- Drive adoption of CDISC standards, regulatory requirements, and industry best practices across clinical programming activities.
- Lead process improvement and automation initiatives that enhance scalability, reduce cycle times, and improve data quality.
- Partner with Clinical Data Management, Biostatistics, Clinical Operations, and external vendors to optimize data flows, study execution, and operational effectiveness.
- Author, review, and enhance standard operating procedures, work instructions, and programming documentation.
- Identify and mitigate technical, operational, and study-level risks while influencing resolution strategies across stakeholders.
Qualifications / Skills- Typically requires a Bachelor's degree in Computer Science, Mathematics, Statistics, Life Sciences, or a related discipline; advanced degree preferred.
- Typically requires 10+ years of progressive clinical programming experience within the biotechnology, pharmaceutical, or CRO industry.
- Advanced expertise in SAS and/or R programming for clinical development and regulatory reporting.
- Demonstrated expertise in GCP, CDISC standards (including SDTM and ADaM), clinical trial data flows, and regulatory submission requirements.
- Proven ability to lead complex cross-functional initiatives and influence outcomes without direct authority.
- Experience driving programming standards, process improvements, automation initiatives, or enterprise-wide best practices.
- Strong communication, collaboration, and problem-solving skills with the ability to translate technical concepts for diverse audiences.
Salary Range: $155,000.00 to $202,000.00 . Compensation for the role will depend on a number of factors, including a candidate's qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at https://www.denalitherapeutics.com/careers
This compensation and benefits information is based on Denali's good faith estimate as of the date of publication and may be modified in the future.
