About this role
Provide statistical leadership for immunology-related clinical development and life-cycle management programs. Own statistical strategy, protocols, and statistical analysis plans to support design, analysis, reporting, and regulatory submissions.
Key Responsibilities
- Provide statistical support for clinical development projects through own efforts or those of a team
- Lead/develop statistical strategy for project development and regulatory submission
- Independently develop protocols and statistical analysis plans
- Ensure statistical analyses in protocols and analysis plans are conducted appropriately
- Liaison for statistical issues on collaborative studies with CROs, academic institutions, government agencies, and committees
Technical Overview
Lead statistical methodology for clinical trials and scientific programs, including development of protocols and statistical analysis plans. Validate external statistical software for SOP and regulatory compliance and ensure accurate statistical deliverables for internal and publication use.
Ideal Candidate
The ideal candidate is a PhD or MS with 10+ years of experience leading statistical work for immunology-focused clinical development. They independently develop protocols and statistical analysis plans, drive statistical strategy for regulatory submissions, and partner cross-functionally across Clinical, Regulatory, Patient Safety, and Global Medical Affairs (GMA).
Must-Have Skills
MS (with 10+ years of experience) or PhDProvide statistical support for one or more clinical development projectsLead/develop statistical strategy for project development and regulatory submissionIndependently develop protocols and statistical analysis plansEnsure applicable regulatory requirements for work processes are met
Tools & Platforms
global medical affairs (GMA)CROsexternal statistical software
Required Skills
statistical leadershipclinical developmentlife-cycle management strategiesclinical trialspatient safetyglobal medical affairs (GMA)statistical supportstatistical strategyregulatory submissiondesign of scientific studiesprotocolsstatistical analysis plansanalysisreportingdata presentation and inferenceinterpretation of statistical deliverablespublication of scientific researchaccuracy and internal consistencyliaison with CROs and external collaboratorsregulatory requirements complianceregulatory submission document reviewdiscussions with regulatory agenciesvalidate external statistical softwareSOP compliancementor staffsupervise contract statisticianssupervise junior statisticians
Hard Skills
statistical leadershipclinical developmentlife-cycle management strategiesclinical trialspatient safetyglobal medical affairs (GMA)statistical support for clinical development projectsstatistical strategyregulatory submissiondesign of experimentsanalysisreportingstatistical methodologystatistical concepts and methodologyprotocolsstatistical analysis plansstatistical input to compound/drug developmentdesign and analysis and reportingdata presentation and inferencestatistical deliverables interpretationscientific research programspublication support for scientific researchaccuracy and internal consistency of reports and publicationstableslistingsfiguresliaison for statistical issues on collaborative studiesCRO collaborationacademic institutions collaborationgovernment agencies collaborationsteering committeesdata monitoring committeesjoint ventures collaborationlicensing collaborators collaborationregulatory requirements complianceregulatory submission document reviewregulatory agency discussionsexternal statistical software validationSOP compliancementor staff on statistical methodology and operationssupervise contract statisticianssupervise junior statisticiansdevelop protocolsvalidate external statistical software
Soft Skills
cross-functional collaborationpartnership with experts in multiple disciplinesleadershipmentoringtrainingindependent developmentcritical thinkingcommunicationalignment with functional management
Keywords for Your Resume
Associate DirectorStatisticsStatistics - Immunologyimmunologystatistical leadershipclinical developmentlife-cycle management strategiesclinical trialspatient safetyglobal medical affairs (GMA)statistical strategyregulatory submissionprotocolsstatistical analysis plansdesignanalysisreportingdata presentation and inferencestatistical deliverablesregulatory requirementsregulatory agencyvalidate external statistical softwareSOPsCROdata monitoring committees
Deal Breakers
Must have MS (with 10+ years of experience) or PhD, Must demonstrate experience leading statistical strategy for project development and regulatory submission, Must be able to independently develop protocols and statistical analysis plans
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