The Director of Statistical Programming is a pivotal, newly created role at LB Pharmaceuticals, reflecting our commitment to building a best-in-class internal Biometrics capability. This individual will serve as the founding leader of our Statistical Programming function, responsible for building the team, infrastructure, and processes from the ground up. The Director will be a hands-on technical leader and strategic partner, working closely with the VP of Biometrics, Biostatistics, Clinical Operations, and Regulatory Affairs to support late-stage clinical trials and BLA submission planning.
Responsibilities
Team & Infrastructure Building
- Establish and lead the internal Statistical Programming function, defining organizational structure, hiring plans, and resourcing strategy as the company scales toward BLA.
- Design and implement the programming infrastructure, including SAS/R environments, standard macros, validation frameworks, SDTM/ADaM libraries, and TLF shells aligned with CDISC standards.
- Develop and maintain SOPs, work instructions, and best practices for all statistical programming activities.
- Recruit, mentor, and grow a high-performing team of statistical programmers (contractors and FTEs) over time.
Hands-On Programming & Deliverables
- Serve as lead programmer on CNS clinical trials (schizophrenia, bipolar depression, MDD), including Phase 2 and Phase 3 studies.
- Develop and validate SDTM and ADaM datasets, TLFs, and supporting documentation for regulatory submissions in full compliance with FDA and ICH guidelines.
- Lead statistical programming activities for IND/NDA/BLA submissions, including Integrated Summary of Safety (ISS), Integrated Summary of Efficacy (ISE), eCTD packaging, Define.xml, Reviewer's Guide, and CDISC compliance checks.
- Collaborate with Biostatistics to implement statistical analysis plans (SAPs) and provide programming support for ad hoc analyses.
Vendor Oversight & Governance
- Oversee and manage CRO/vendor statistical programming activities, including scope of work definition, timeline management, quality review, and deliverable acceptance.
- Establish vendor governance frameworks including quality oversight plans, technical review checklists, and escalation pathways.
- Ensure vendor-produced datasets, TLFs, and submission packages meet internal and regulatory standards prior to acceptance.
Regulatory & Cross-Functional Collaboration
- Partner with Regulatory Affairs and Biostatistics to develop and execute the BLA submission strategy and data package planning for LB-102.
- Liaise with FDA on data standards, submission requirements, and any technical queries related to statistical programming deliverables.
- Collaborate with Clinical Data Management to ensure alignment on data flow, edit checks, database lock timelines, and data quality.
- Contribute to Health Authority meetings and respond to regulatory requests related to statistical programming.
Qualifications
- Bachelor's or Master's degree in Statistics, Computer Science, Mathematics, or a related quantitative field.
- Minimum 10 years of statistical programming experience in the pharmaceutical or biotech industry, with at least 3 years in a leadership or senior role.
- Demonstrated experience supporting NDA or BLA submissions, including hands-on SDTM/ADaM development and regulatory-grade TLF production.
- Deep expertise in SAS (Base, Macro, STAT, ODS); proficiency in R is highly desirable.
- Strong working knowledge of CDISC standards (SDTM, ADaM, SEND, Define.xml) and FDA/ICH submission guidelines (including 21 CFR Part 11).
- Proven ability to manage and oversee CRO/vendor programming deliverables in a sponsor oversight capacity.
- Experience in a small or mid-size biotech environment, including comfort with ambiguity and ability to build processes from scratch.
- Experience in CNS therapeutic areas, particularly schizophrenia, bipolar disorder, or MDD preferred.
- Familiarity with FDA expectations for CNS endpoint programming (e.g., PANSS, MADRS, YMRS, CGI scales) preferred.
- Prior experience building or standing up a statistical programming function at a growing biotech preferred. .
- PharmaSUG, CDISC, or equivalent industry certifications preferred.
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: $233,175-$244,130.
