Lead Statistical Programming Manager

Pulmovant; United States; On-site; USD 140,000 - 200,000; Full time

Job summary

Pulmovant is seeking a Manager or Senior Manager of Statistical Programming to support development and submission-ready programming deliverables across our pulmonary/respiratory portfolio.

This role leads programming on clinical studies and regulatory submissions, collaborating with Biostatistics, Data Management, Regulatory Affairs, and Clinical Development to ensure CDISC-compliant datasets meet high standards.

Qualifications

• 5+ years of statistical programming experience in pharma/biotech/CRO.
• Lead programmer on late-phase (Phase 2b/3) studies and regulatory submissions preferred.
• Strong knowledge of CDISC SDTM/ADaM, FDA eCTD, and define.xml.
• Familiar with GCP/ICH guidelines and data submission expectations.

Responsibilities

• Develop and maintain CDISC-compliant SDTM/ADaM datasets, TLFs, and figures.
• Lead programmer for assigned studies; write specs, QC plans, and define.xml.
• Ensure audit-ready deliverables aligned with SAPs and regulatory guidelines (FDA/EMA).
• Develop reusable SAS macros and R packages to improve efficiency.
• Oversee timelines and CRO vendor programming activities; mentor junior staff.

Skills

Attention to detail

SAS proficiency

R programming

Python

Regulatory submissions

Education

Bachelor's degree in Statistics/Math/CS

Master's degree preferred

Tools

SAS

R

Git

Job description

Pulmovant is seeking a Manager or Senior Manager of Statistical Programming to support development and submission-ready programming deliverables across our pulmonary/respiratory portfolio.

This role leads programming on clinical studies and regulatory submissions, collaborating with Biostatistics, Data Management, Regulatory Affairs, and Clinical Development to ensure CDISC-compliant datasets meet high standards.