Remote Senior Manager, Statistical Programming

Pulmovant

Northern (KY)

Hybrid

USD 140,000 - 230,000

Full time

4 days ago

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Job summary

Pulmovant is seeking a Manager or Senior Manager of Statistical Programming to support the development and delivery of high‑quality, submission‑ready programming deliverables across our pulmonary/respiratory portfolio.

This individual will serve as a lead programmer on clinical studies and regulatory submissions, working closely with Biostatistics, Data Management, Regulatory Affairs, and Clinical Development to ensure that all CDISC‑compliant datasets, TLFs, and electronic submission packages

Qualifications

Bachelors in statistics, mathematics, computer science or related field; advanced degree preferred.
5+ years in statistical programming in pharma/biotech/CRO environments.
Expert in SAS (Base, Macro, STAT, GRAPH) and CDISC SDTM/ADaM.
Experience leading late-stage clinical programming and regulatory submissions.
Strong understanding of FDA/EMA data submission expectations and GCP/ICH guidelines.

Responsibilities

Develop, validate, and maintain SAS/R programs to produce CDISC-compliant SDTM/ADaM datasets, tables, listings, and figures (TLFs).
Serve as lead programmer for Phase 2b/3 studies; author QC plans and define.xml.
Ensure audit-ready deliverables aligned with SAPs and regulatory guidelines.
Mentor junior programmers and oversee CRO/vendor programming deliverables.
Lead or support NDA/BLA/IND submissions and regulatory data requests.