Manager/Senior Manager, Statistical Programming

Pulmovant

. Develop, validate, and maintain SAS and R programs to produce CDISC-compliant SDTM and ADaM datasets, tables, listings, and figures (TLFs) for clinical studies and regulatory submissions .

Posted 9/28/2026full-timeRemote • United StatesSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates advanced proficiency in SAS and R for statistical programming, with a strong understanding of CDISC standards and regulatory submission requirements. Capable of leading programming activities for clinical studies and managing timelines while ensuring compliance with FDA/EMA guidelines.

Highest-signal resume keywords

Advanced Proficiency In SASStatistical Programming In RCDISC Standards KnowledgeLead Programmer ExperienceNDA/BLA Submission Support

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

SAS ProgrammingR ProgrammingStatistical AnalysisCDISC SDTMCDISC ADaMRegulatory Submission RequirementsProgramming Specifications AuthoringQuality Control PlansData Standards ComplianceStatistical Reporting

Soft Skills

Attention To DetailCommunication SkillsProject ManagementMentoringCollaboration

Tools & Technologies

SAS Macro LibrariesAutomation ToolsVersion Control (Git)Cloud-Based Programming EnvironmentsECRF Designs

Certifications & Qualifications

SAS Certification (Base, Advanced, Clinical Trials Programming)

Industry Keywords

Clinical StudiesRegulatory SubmissionsFDAEMAICH GuidelinesPharmaBiotechCROReal-World Evidence (RWE)Pulmonary Therapeutic Area

Tech Stack

Tools & technologies

CloudGoogle Cloud PlatformPython

About the role

Key responsibilities & impact

Develop, validate, and maintain SAS and R programs to produce CDISC-compliant SDTM and ADaM datasets, tables, listings, and figures (TLFs) for clinical studies and regulatory submissions
Serve as lead programmer for assigned Phase 2b/3 studies; author and review programming specifications, QC plans, and define.xml files
Ensure all deliverables are audit-ready and aligned with SAPs, protocols, and applicable FDA/EMA/ICH regulatory guidelines
Contribute to the development and maintenance of reusable SAS macro libraries, R packages, and programming standards
Lead or support statistical programming activities for NDA/BLA/IND submissions, including integrated summaries of safety (ISS) and efficacy (ISE), CSRs, and ad hoc regulatory requests
Ensure compliance with CDISC SDTM/ADaM implementation guides, FDA Data Standards Catalog, and eCTD submission requirements; author and review Reviewer's Guides and define.xml
Review and provide input on eCRF designs, external data transfer specifications, central lab/imaging specifications, and protocol deviation plans
Represent Statistical Programming at study team meetings; collaborate with Biostatisticians, Data Management, Medical Writing, Clinical Operations, and Regulatory Affairs
Plan and manage programming timelines and resources; oversee and quality-check deliverables from CROs and external programming vendors
Contribute to or lead departmental SOPs, work instructions, and process improvement initiatives
Mentor junior statistical programmers; provide technical guidance, code review, and professional development support
At the Senior Manager level, may manage 1–2 direct reports and provide input on hiring, performance, and team-building

Requirements

What you’ll need

Bachelor's degree in Statistics, Mathematics, Computer Science, or a related field; Master's degree preferred
5–7+ years of statistical programming experience in pharma, biotech, or a CRO (Manager: 5+ years; Senior Manager: 7+ years)
Advanced proficiency in SAS (Base, Macro, STAT, GRAPH) required
Thorough knowledge of CDISC standards (SDTM, ADaM, CDASH) and regulatory submission requirements (FDA eCTD, define.xml, Reviewer's Guides)
Proven experience as lead programmer on at least one late-phase (Phase 2b/3) clinical study and/or regulatory submission
Strong understanding of GCP, ICH E3/E9 guidelines, and FDA/EMA data submission expectations
Excellent attention to detail, communication skills, and ability to manage multiple projects and priorities simultaneously
Proficiency in R for statistical programming and reporting; familiarity with Python a plus
Experience supporting NDA/BLA submissions and responding to health authority queries
Familiarity with automation tools, version control (Git), and/or cloud-based programming environments
Exposure to real-world evidence (RWE) datasets or adaptive trial designs
Experience in pulmonary, respiratory, or rare disease therapeutic areas
SAS certification (Base, Advanced, or Clinical Trials Programming) a plus