Head of Statistical Programming & Data Infrastructure

JobRx, Inc.; New York (NY); On-site; USD 233,000 - 244,000; Full time

Job summary

LB Pharmaceuticals seeks a Director of Statistical Programming to build and lead a new internal programming function. You will design the infrastructure, set standards, and act as a hands-on technical leader partnering with Biostatistics, Regulatory Affairs and Clinical Operations.

The role requires 10+ years in statistical programming within pharma/biotech, deep SAS experience, CDISC expertise, and a track record in NDA/BLA submissions.

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 pharma/biotech with at least 3 years in leadership.
• 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 knowledge of CDISC standards and FDA/ICH submission guidelines (21 CFR Part 11).

Responsibilities

• Lead internal Statistical Programming function, define org structure and hiring plans.
• Design and implement programming infrastructure (SAS/R environments, SDTM/ADaM libraries).
• Develop SOPs and best practices for programming activities.
• Recruit, mentor, and grow the programming team.
• Lead programming for CNS trials (Phase 2/3) and regulatory submissions (IND/NDA/BLA).
• Collaborate with Biostatistics on SAPs and ad hoc analyses.
• Oversee CRO/vendor programming deliverables and governance.

Skills

SAS

R

CDISC standards

FDA/ICH submissions

leadership

Education

Bachelor's or Master's in Statistics/CS/Math

Tools

SAS macros

Define.xml tooling

Job description

LB Pharmaceuticals seeks a Director of Statistical Programming to build and lead a new internal programming function. You will design the infrastructure, set standards, and act as a hands-on technical leader partnering with Biostatistics, Regulatory Affairs and Clinical Operations.

The role requires 10+ years in statistical programming within pharma/biotech, deep SAS experience, CDISC expertise, and a track record in NDA/BLA submissions.