The Senior Director of Statistical Programming is responsible for the strategic direction, operational execution, people leadership, and quality of the Statistical Programming function at LB Pharmaceuticals. Reporting to the VP of Biometrics, this leader will oversee statistical programming across Phase 2 and Phase 3 clinical programs, integrated analyses, and NDA submission activities.
This role will own and scale the function, lead internal employees and external programming vendors, manage portfolio-level resources, and establish the operating model required to support late-stage development and regulatory submissions.
The Senior Director is expected to spend approximately 30-40% of their time in hands-on technical programming and review and 60-70% leading the organization through people management, vendor oversight, portfolio planning, quality governance, and cross-functional leadership. The successful candidate will maintain deep technical credibility while operating primarily as a functional and organizational leader.
Key Responsibilities
Functional & Organizational Leadership
- Own the overall strategy, operating model, and delivery framework for Statistical Programming across the clinical development portfolio.
- Build and scale a high-performing organization of employees, contractors, and external programming partners.
- Establish organizational structure, staffing plans, career paths, performance expectations, and succession planning.
- Recruit, mentor, and retain high-caliber statistical programming talent.
- Allocate programming resources across competing study and submission priorities and proactively address capacity and delivery risks.
- Develop and manage the Statistical Programming functional budget in partnership with Biometrics and Finance.
- Establish KPIs and provide senior leadership with visibility into capacity, quality, timelines, and risks.
Technical Leadership
- Remain actively engaged in statistical programming, technical review, and complex problem-solving.
- Serve as senior technical lead for strategically important or high-risk Phase 2/3 studies and analyses.
- Develop and review SDTM and ADaM datasets, TLFs, programming specifications, and supporting documentation.
- Support implementation of SAPs in partnership with Biostatistics.
- Maintain expertise in SAS and relevant programming technologies, with R experience strongly preferred.
- Establish and maintain programming standards, reusable code, validation approaches, and efficient programming practices.
- Ensure technical work is accurate, reproducible, traceable, and inspection ready.
Regulatory Submission Leadership
- Lead the Statistical Programming strategy for NDA preparation and submission activities.
- Oversee programming deliverables for ISS, ISE, integrated analyses, submission datasets, TLFs, Define.xml, Reviewer's Guide, and related documentation.
- Ensure compliance with CDISC, FDA, ICH, and applicable data standards and regulatory expectations.
- Partner with Regulatory Affairs, Biostatistics, Data Management, and Medical Writing on submission planning and execution.
- Provide programming expertise for Health Authority interactions and responses to regulatory questions.
- Ensure the function is inspection-ready and capable of supporting regulatory review.
Vendor & CRO Management
- Own the strategic management and governance of external statistical programming vendors and CROs.
- Establish appropriate internal versus external programming delivery models.
- Lead vendor selection, scope definition, resource planning, and performance management.
- Establish clear expectations for technical standards, timelines, quality, documentation, and escalation.
- Monitor vendor performance and resolve significant technical, quality, resource, and timeline issues.
- Ensure vendor deliverables meet LB Pharmaceuticals' standards before acceptance.
Quality, Standards & Infrastructure
- Own the Statistical Programming quality and governance framework.
- Establish and maintain SOPs, work instructions, programming standards, validation requirements, and documentation practices.
- Ensure consistent application of CDISC standards, including SDTM, ADaM, and Define.xml.
- Establish quality metrics, risk-management processes, and continuous-improvement initiatives.
- Provide strategic direction for SAS/R environments, programming libraries, automation, version control, and other technology supporting the function.
- Ensure programming systems and processes are secure, compliant, scalable, and appropriately validated.
Cross-Functional Leadership
- Serve as the senior Statistical Programming partner to Biometrics, Biostatistics, Clinical Development, Clinical Operations, Data Management, Regulatory Affairs, and Medical Writing.
- Translate technical programming issues into clear business implications, risks, and recommendations for senior leadership.
- Align programming resources and timelines with clinical development milestones, database locks, analyses, and regulatory submissions.
- Represent Statistical Programming in cross-functional governance and study teams.
Qualifications
Required
- Bachelor's or Master's degree in Statistics, Biostatistics, Computer Science, Mathematics, or related quantitative discipline.
- 12+ years of statistical programming experience in pharmaceutical, biotechnology, or related life sciences.
- 5+ years of progressive leadership experience, including management of statistical programming professionals and/or programming leaders.
- Extensive experience supporting Phase 2/3 clinical development and NDA submissions.
- Demonstrated expertise in regulatory-grade SDTM, ADaM, TLFs, Define.xml, integrated analyses, and submission documentation.
- Advanced SAS expertise; working knowledge of R strongly preferred.
- Deep knowledge of CDISC standards and FDA/ICH requirements for clinical trial data.
- Demonstrated experience managing CRO and vendor programming activities from a sponsor perspective.
- Proven ability to build and scale programming processes, teams, and infrastructure.
- Strong understanding of programming validation, quality control, traceability, and inspection readiness.
- Experience working effectively in a small or mid-size biotech environment with evolving priorities.
Preferred
- CNS experience, particularly schizophrenia, bipolar depression, MDD, or related indications.
- Familiarity with PANSS, MADRS, YMRS, CGI-S, and CGI-I.
- Experience building or scaling a sponsor-side Statistical Programming organization.
- Experience transitioning programming activities between internal and outsourced models.
- Experience with global clinical development programs and FDA interactions.
- Participation in PharmaSUG, CDISC, or other relevant industry organizations.
Leadership Competencies
Strategic Leader: Translates clinical and regulatory objectives into a clear Statistical Programming strategy and operating model.
People Developer: Builds, develops, and retains high-performing technical teams and future leaders.
Technical Authority: Maintains hands-on programming expertise and provides senior technical oversight for complex and high-risk deliverables.
Portfolio Leader: Effectively prioritizes resources across studies, programs, vendors, and submission milestones.
Vendor Leader: Establishes accountable, high-performing relationships with CROs and external programming partners.
Regulatory & Quality Focused: Maintains rigorous standards for data integrity, validation, traceability, compliance, and inspection readiness.
Executive Communicator: Clearly communicates complex technical issues, risks, and recommendations to senior leadership.
Builder & Scaler: Evolves the function from a developing capability into a mature, scalable organization capable of supporting multiple late-stage programs and regulatory submissions.
The posted salary range reflects the minimum to maximum base pay for this position in the specified location. Actual compensation may vary based on factors such as geographic location, experience, education, licensure requirements, and skill level, and will be determined at the time of offer. Base Salary Range: $271K-$285K.
