Manager/Senior Manager, Statistical Programming

Role Summary:

• Pulmovant is seeking a Manager or Senior Manager of Statistical Programming to support high-quality, submission-ready programming deliverables.
• The role involves leading clinical studies and regulatory submissions, working closely with Biostatistics, Data Management, and Regulatory Affairs.

Key Responsibilities:

• Develop, validate, and maintain SAS and R programs for CDISC-compliant SDTM/ADaM datasets and TLFs.
• Serve as lead programmer for Phase 2b/3 studies and contribute to NDA/BLA/IND submissions, including ISS/ISE.
• Ensure compliance with CDISC, FDA/EMA guidelines, and eCTD requirements; manage CRO deliverables and timelines.

Qualifications:

• Bachelor's degree in Statistics, Mathematics, Computer Science, or related field; Master's preferred.
• 5-7+ years of statistical programming experience in pharma, biotech, or CRO; advanced SAS proficiency required.
• Strong knowledge of CDISC standards, regulatory submission requirements, and experience as lead programmer on late-phase studies.

About Pulmovant:

• Pulmovant is a Roivant-backed clinical-stage biotech focused on pulmonary diseases with a promising investigational candidate.
• Positive Phase 2 results for mosliciguat position it as a potential first-in-class treatment for PH-ILD, with a Phase 3 trial underway.