Vice President, Biostatistics and Programming

Worldwide Clinical Trials•Durham, NC

About The Position

The Vice President, Biostatistics and Programming provides strategic leadership and executive oversight for the company’s global Biostatistics and Programming function. This role is responsible for setting the vision, operational framework, and standards that ensure high‑quality statistical and programming deliverables across clinical development programs. As the global leader of Biostatistics and Programming, the Vice President directs the planning, analysis, and interpretation of data from individual clinical studies and integrated clinical programs. This position oversees the development, review, and approval of regulatory deliverables, including submissions such as NDAs, in accordance with SOPs and study‑specific guidelines. The Vice President leads departmental strategy and execution, evaluates key performance indicators, supports business development initiatives, and maintains financial oversight of the function. Full accountability includes the recruitment, retention, and development of high‑performing biostatistics and programming teams worldwide. As a key member of the Worldwide Flex Leadership Team, the Vice President, Biostatistics and Programming plays a critical role in advancing organizational strategy, enabling regulatory success, and delivering data‑driven insights that support clinical and business decision‑making.

Requirements

Extensive knowledge of clinical trial study design across multiple therapeutic areas, including oncology.
Advanced expertise in SAS and related statistical and programming tools.
Proven ability to lead independently, direct cross‑functional teams, and engage effectively with executive leadership.
Strong strategic, analytical, problem‑solving, and organizational skills with high attention to detail.
Ability to manage multiple priorities and deliver results in a fast‑paced, changing environment.
Excellent written, verbal, and presentation communication skills; effective global communicator with time zone awareness.
Strong interpersonal skills, with the ability to collaborate across diverse functions and organizational levels.
Demonstrated experience developing departmental strategies and mentoring and developing high‑performing teams.
Financial, budget management, and commercial acumen.
Proficiency with Microsoft Office Suite and strong digital systems aptitude.
Flexible, innovative, and results‑driven team player with a commitment to excellence.
Willingness and ability to travel domestically and internationally as required.
Master’s degree, equivalent, or higher in biostatistics or a related field.
A satisfactory combination of education and experience may be accepted as a substitute for the specific education and experience listed above.
A minimum of 15+ years of relevant work experience
A minimum of 7+ years of biostatistics and programming line management experience.
Previous experience in a pharmaceutical research or CRO setting required.
Previous experience in multiple therapeutic areas.

Responsibilities

Provide executive oversight across multiple clinical research programs, complex submissions (e.g., NDAs), and global client relationships.
Set strategy and lead the global Biostatistics and Programming department, ensuring high‑quality, compliant, and timely delivery.
Oversee operational execution within contractual scope, serving as an escalation point for project and client issues as needed.
Recruit, develop, mentor, and retain biostatistics and programming leaders and staff, with full accountability for performance management and workforce planning.
Establish, maintain, and optimize department SOPs, processes, metrics, best practices, and utilization.
Provide advanced technical leadership to support statistical analysis, programming, and reporting solutions across studies and programs.
Drive financial oversight for the department, including budgeting and non‑billable travel approvals.
Partner with commercial and business development teams to support proposals, bids, and client presentations.
Provide strategic input into technology and future‑state capabilities.
Represent the department and company in cross‑functional forums, client meetings, bid defenses, and industry events.
Act as a biostatistics and programming champion, promoting innovation, quality, and operational excellence across the organization.