Executive Director, Statistical Programming

Executive Director, Statistical Programming

This senior leadership role sits at the core of biometrics and clinical development, responsible for shaping and leading the statistical programming function across all clinical programs. It offers a unique opportunity to drive both strategic direction and hands-on execution for high-impact regulatory and clinical submissions in a fast-paced, global environment. The position oversees the development of robust programming standards, ensures the quality and timeliness of analysis datasets and statistical outputs, and enables data-driven decision-making across development programs. Working closely with statisticians, clinical teams, and external partners, this leader ensures seamless integration of programming activities from study design through submission. The role also plays a key part in advancing innovation, process excellence, and scalability within biometrics operations. It is a high-visibility leadership position with direct impact on regulatory success and the delivery of therapies for rare diseases.

Accountabilities:

• Lead the Statistical Programming function within Biometrics, setting strategic direction and ensuring delivery of high-quality programming outputs across all clinical development programs.
• Oversee end-to-end programming deliverables supporting clinical studies, including analysis datasets, TLFs, ISS/ISE, DSUR, PSUR, IBs, and regulatory submission packages.
• Provide hands-on leadership for statistical programming activities, ensuring timely, accurate, and compliant production of clinical reporting outputs.
• Collaborate with statisticians, clinical teams, data management, and external vendors to ensure alignment on study design, SAPs, and programming specifications.
• Ensure quality, consistency, and compliance of all programming deliverables with regulatory standards and internal SOPs.
• Lead development, maintenance, and continuous improvement of programming standards, SOPs, technical documentation, and validation frameworks.
• Oversee vendor management, including CRO oversight, qualifications, and performance monitoring in collaboration with quality teams.
• Drive innovation in programming methodologies, tools, and systems to improve scalability, efficiency, and data-driven decision-making.
• Manage, mentor, and develop statistical programming teams, fostering technical excellence and professional growth.
• Represent Biometrics in cross-functional initiatives, supporting process improvement and organizational effectiveness.

Requirements:

• Bachelor's degree in Statistics, Computer Science, Mathematics, or related technical field required; Master's preferred or equivalent experience accepted.
• 14+ years of clinical SAS programming experience in pharmaceutical or CRO environments across Phase I–IV clinical trials.
• At least 7+ years of leadership experience managing statistical programming teams and large-scale clinical deliverables.
• Strong expertise in SDTM, ADaM, Define.xml, and CDISC standards.
• Deep understanding of clinical development, regulatory submission processes, and global requirements (FDA, ICH, GCP, eCTD, etc.).
• Advanced proficiency in SAS (including macros, SQL, ODS, STAT, GRAPH, ACCESS) and strong knowledge of programming environments (Unix/Windows).
• Experience supporting regulatory submissions and ensuring compliance in high-stakes development programs.
• Proven ability to manage vendors, CROs, and cross-functional stakeholders effectively.
• Strong leadership, communication, and stakeholder management skills in complex matrix environments.
• Familiarity with R programming is a plus, along with strong knowledge of software development lifecycle principles.
• Ability to operate in a fast-paced, highly regulated, and dynamic clinical environment.
• Willingness to travel up to 10% domestically and internationally.

Benefits:

• Competitive base salary range: $246,000 – $332,000.
• Short-term incentive bonus and long-term equity (stock) compensation opportunities.
• Comprehensive health, dental, and vision insurance for employees and dependents.
• Retirement plan with employer matching contributions.
• Life insurance and disability coverage.
• Generous paid time off and flexible work-life balance support.
• Wellness programs and employee assistance resources.
• Financial, health, and well-being benefits designed to support employees and families.