Director/Principal, Statistical Programming

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 programmer and strategic partner, working closely with the VP of Biometrics, Biostatistics, Clinical Operations, and Regulatory Affairs to support late-stage clinical trials and NDA submission planning.

Responsibilities

Infrastructure Building

• 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.

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 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.
• Ens