About this role
AbbVie is looking for an Associate Director, Statistics to provide statistical leadership for clinical development and life-cycle management strategies. This role covers work across clinical trials, patient safety, and global medical affairs, including regulatory submission strategy and benefit-risk planning.
Key Responsibilities
- Provide statistical leadership for design, analysis and reporting for clinical or scientific research programs
- Independently develop protocols and statistical analysis plans, including product safety analysis plans and integrated safety planning
- Represent statistics on project teams and partner with Clinical, Regulatory, Patient Safety, or GMA to drive development strategy alignment
- Train and mentor staff and supervise contract statisticians or junior statisticians
- Serve as liaison for statistical issues on collaborative studies with CROs, academic institutions, and government agencies; validate external statistical software
Technical Overview
The Associate Director, Statistics will independently develop protocols and statistical analysis plans (including product safety analysis plans and integrated safety evidence planning). They will ensure analyses are performed appropriately, validate external statistical software against Standard Operating Procedures (SOPs) and regulatory requirements, and produce accurate statistical deliverables (tables, listings, figures) to support regulatory evidence generation and safety benefit-risk assessment.
Ideal Candidate
The ideal candidate is a senior statistics leader who provides statistical leadership for clinical development and life-cycle management strategies, including clinical trials, patient safety, and global medical affairs. They independently develop protocols and statistical analysis plans, conduct and validate analyses per scientific protocols and analysis plans, and critically review regulatory submission documents. They partner across functions and with external CROs to deliver accurate statistical deliverables that support benefit-risk assessment and regulatory evidence generation.
Must-Have Skills
statistical leadership for clinical development and life-cycle management strategiesindependently develop protocols and statistical analysis plansensure statistical analyses specified in scientific protocols and analysis plans are conducted appropriatelycritical review regulatory submission documentsbenefit-risk planning and assessment (SSG)collaboration with cross-functional teams to provide statistical input to compound/drug development
Tools & Platforms
external statistical softwareStandard Operating Procedures (SOPs)
Required Skills
statistical leadershipclinical developmentlife-cycle managementclinical trialspatient safetyglobal medical affairsregulatory submission strategyprotocolsstatistical analysis plansproduct safety analysis plansintegrated summary of safety analysis plansanalysis plansbenefit-risk planning and assessmentsafety outputsdata presentation and inferencepublication of scientific researchinternal consistency of reportstableslistingsfiguresCRO collaborationacademic institutions collaborationgovernment agencies collaborationdata monitoring committeesexternal statistical software validationStandard Operating Procedures (SOPs)validate external statistical softwarecross-functional partnership
Hard Skills
statistical leadershipclinical developmentlife-cycle management strategyclinical trialspatient safetyglobal medical affairsregulatory submission strategy planningproduct life-cycle management strategy planningstatistical leadership for designanalysis and reportingprotocol developmentstatistical analysis plansproduct safety analysis plansintegrated summary of safety analysis plansanalysis plans for GMA evidence generationregulatory submission documentscritical review of regulatory submission documentsstatistical methodologypropose novel statistical methodological approachesstatistical analysis executionprogramming implementation supportdata presentationinferencestatistical deliverablesinterpretation of statistical deliverablespublication of scientific researchaccuracy and internal consistency of reports and publicationstableslistingsfiguresliaison for statistical issuesexternal statistical software validationStandard Operating Procedures (SOPs)regulatory requirements validationsafety outputsbenefit-risk planning and assessmentBenefit-risk planninggraphics (safety output graphics)data monitoring committeesData Monitoring Committee (DMC)CRO collaborationacademic institutions collaborationgovernment agencies collaborationsteering committees collaborationjoint ventureslicensing collaborators
Soft Skills
partnership with experts in multiple disciplinestraining and mentoring staffleadershipsupervision of contract statisticianscollaboration with cross-functional teamsliaison communicationexternal scientific connection buildingscientific discussion with regulatory agenciesstakeholder alignment
Keywords for Your Resume
Associate DirectorStatisticsstatistical leadershipclinical developmentlife-cycle managementclinical trialspatient safetyglobal medical affairsregulatory submissionproduct life-cycle management strategyprotocolsstatistical analysis plansproduct safety analysis plansintegrated summary of safety analysis plansanalysis plansbenefit-risk planning and assessmentsafety outputssafety analysisdata presentationinferencepublication of scientific researchinternal consistencytableslistingsfiguresCROacademic institutionsgovernment agenciessteering and/or data monitoring committeesdata monitoring committeesexternal statistical softwareStandard Operating Procedures (SOPs)validate external statistical softwarelife-cycle management strategy
Deal Breakers
Must have experience independently developing protocols and statistical analysis plans, Must have experience with regulatory submission statistical leadership and critical review of regulatory submission documents, Must demonstrate benefit-risk planning and assessment leadership (SSG)
Get matched to jobs like this
Luna finds roles that fit your skills and career goals — no endless scrolling required.
Create a Free Profile