Director of Statistical Programming

BridgeBio
United States
Workplace: RemoteFull timeUSD 241,600 - 269,200Function: Executive & General ManagementExperience: 10+ yearsEducation: mastersSkills: ["Leadership","Cross-functional collaboration","Attention to compliance","Project management","Stakeholder communication"]

Lead statistical programming for multiple clinical studies, ensuring high-quality, cross-study consistent deliverables and timely submission readiness. Oversee CRO programming outputs with acceptance checks against CDISC standards, and execute work across study monitoring, clinical study reports, data integrations, and regulatory queries. Build and automate SAS reporting environments, programming infrastructure, and utility macros while bringing modern methods and AI-assisted tooling to improve efficiency and compliance. Represent statistical programming in cross-functional study teams and define standards, processes, and SOPs.

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FursaFursa
BridgeBio
BridgeBio
13 hours ago

Director of Statistical Programming

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Last checked: 11 hours agoStatus: Live

Job Summary

Lead statistical programming for multiple clinical studies, ensuring high-quality, cross-study consistent deliverables and timely submission readiness. Oversee CRO programming outputs with acceptance checks against CDISC standards, and execute work across study monitoring, clinical study reports, data integrations, and regulatory queries. Build and automate SAS reporting environments, programming infrastructure, and utility macros while bringing modern methods and AI-assisted tooling to improve efficiency and compliance. Represent statistical programming in cross-functional study teams and define standards, processes, and SOPs.
Location: United States
Workplace: Remote
Employment Type: Full time
Job Function: Executive & General Management
Seniority: Director level

Key Responsibilities

  • •Lead and manage statistical programming activities for multiple clinical studies, ensuring timelines, high quality, and cross-study consistency.
  • •Review CRO deliverables and perform acceptance checks/validation for accuracy, completeness, and CDISC compliance.
  • •Manage, review, and/or execute statistical programming deliverables for study monitoring, clinical study reports, data integrations, and regulatory query responses.
  • •Set up SAS reporting environments, programming infrastructure, and utility macros; drive automation and bring state-of-the-art methods and tools.
  • •Set and maintain statistical programming standards, processes, and SOPs; represent the function in cross-functional study teams and establish project timelines.
Travel: Low travel

Pay and Benefits

Salary: USD 241,600 - 269,200
Equity and Bonus:Equity
Perks:Health InsuranceDentalVision401kEquity

Key Requirements

  • •MS in Statistics, Computer Science, or related field with 10+ years of relevant experience, or BS with 12+ years; minimum 5 years as a lead statistical programmer.
  • •Extensive knowledge of CDISC standards and FDA SDTCG.
  • •Experience in statistical programming methods and processes in clinical development.
  • •Ability to manage multiple projects in a fast-paced environment.
  • •Experience with NDA/BLA submission and regulatory & compliance requirements for biostatistics processes.
Experience:10+ yearsBiopharmaClinical trialsCRO oversightRegulatory submissionsCDISC
Education:Master's in Statistics, Computer Science, or a related field
Skills:LeadershipCross-functional collaborationAttention to complianceProject managementStakeholder communication
Languages:English
Tech Stack:SASCDISCFDASDTCGGDPRAI-assisted toolsNDABLA

Company Brief

BridgeBio
Develops medicines for patients with genetic diseases by advancing targeted therapeutics from discovery through clinical development and commercialization, focusing on genetically defined diseases with high unmet medical need.
Industry: Biotech
Company Size: Large (251 to 1,000 employees)
Growth: Public Company
Valuation: Public Company (Market Cap in USD)
Funding: IPO / Publicly Listed
Headquarters: Palo Alto, United States
Founded: 2015
WebsiteLinkedIn