Head of Statistical Programming & Data Infrastructure

LB Pharmaceuticals; New York (NY); On-site; USD 233,000 - 244,000; Full time

Job summary

LB Pharmaceuticals is creating the role of Director of Statistical Programming, the founding leader of our Statistical Programming function. This hands-on leader will design the programming infrastructure, build the team, and partner with Biostatistics and Regulatory Affairs to support late‑stage trials and NDA submission planning.

The role requires deep SAS expertise, CDISC standards (SDTM/ADaM), and proven track record in regulatory submissions, with CRO oversight and governance

Qualifications

• Bachelor’s or Master’s degree in Statistics, Computer Science, Mathematics or related field.
• Minimum 10 years of statistical programming experience in the pharmaceutical/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.

Responsibilities

• Design and build the statistical 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.
• Lead CNS clinical trials as lead programmer for 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.
• 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.

Skills

SAS (Base, Macro, STAT, ODS)

R

CDISC SDTM/ADaM

Regulatory submissions (NDA/BLAs)

Team leadership

Vendor/CRO oversight

FDA/ICH guidelines 21 CFR Part 11

Statistical programming

Education

Bachelor’s or Master’s degree in Statistics, Computer Science, Mathematics

Tools

SAS

R

Job description

LB Pharmaceuticals is creating the role of Director of Statistical Programming, the founding leader of our Statistical Programming function. This hands-on leader will design the programming infrastructure, build the team, and partner with Biostatistics and Regulatory Affairs to support late‑stage trials and NDA submission planning.

The role requires deep SAS expertise, CDISC standards (SDTM/ADaM), and proven track record in regulatory submissions, with CRO oversight and governance