Lead Statistical Programming Architect for CNS Trials

LB Pharmaceuticals; New York (NY); On-site; USD 226,000 - 240,000; Full time

Job summary

LB Pharmaceuticals seeks a Director of Statistical Programming to establish and lead our internal Biometrics function in New York. This founding role will build the team, infrastructure, and processes from the ground up, partnering with the VP of Biometrics, Biostatistics, Clinical Operations, and Regulatory Affairs to support late-stage trials and BLA submission planning.

The successful candidate will be hands-on technically, with expertise in SAS/R, SDTM/ADaM, CDISC standards, and

Qualifications

• 10+ years of statistical programming experience in pharma/biotech.
• 3+ years in a leadership role overseeing programming teams.
• Hands-on SDTM/ADaM development and regulatory-grade TLF production for NDA/BLA submissions.
• Deep expertise in SAS (Base, Macro, STAT, ODS) and CDISC standards.

Responsibilities

• Establish and lead the internal Statistical Programming function, including organizational structure and resourcing.
• Lead CNS/psychiatric trial programming, SDTM/ADaM datasets, TLFs and regulatory documentation.
• Oversee CRO/vendor programming activities with quality reviews and deliverable acceptance.
• Collaborate with Regulatory Affairs/Biostatistics on BLA/NDA submission data packages.

Skills

SAS

R

CDISC

Leadership

NDA/BLA

Team building

Education

Bachelor/Master in stats/compsci/math

Tools

SAS

R

Job description

LB Pharmaceuticals seeks a Director of Statistical Programming to establish and lead our internal Biometrics function in New York. This founding role will build the team, infrastructure, and processes from the ground up, partnering with the VP of Biometrics, Biostatistics, Clinical Operations, and Regulatory Affairs to support late-stage trials and BLA submission planning.

The successful candidate will be hands-on technically, with expertise in SAS/R, SDTM/ADaM, CDISC standards, and