Biostatistics Director guiding clinical trial design, adaptive methods, and statistical consulting. Leading protocol strategy and thought leadership for IQVIA’s life-sciences research services.
Responsibilities
Serve as a thought leader in statistical methodology for clinical trial design
Provide high-level statistical consultancy and guidance to internal and external clients
Specialize in at least one area of statistical leadership and serve as a subject matter expert
Lead the associated statistical leadership work and provide general consulting as needed
Participate in data monitoring committees as a blinded or unblinded statistician
Help write protocol synopses with medical, pharmacokinetic, and operational experts
Contribute occasionally to full protocols and consult on advanced statistical analyses
Publish papers in peer-reviewed journals and perform referee and editor work
Present talks at scientific conferences and participate in invitation-only webinars
Manage people and projects depending on interest
Participate in bid defences
Travel to clients as needed
Requirements
PhD or MSc degree in Statistics, Biostatistics, or related field, along with 11 to 13+ years’ experience within the life-science industry; PhD preferred
Strong knowledge of complex statistical methods that apply to applicable clinical trials
Experience with clinical trial design; adaptive design strongly preferred
Knowledge of regulatory bodies and compliance within the pharmaceutical and CRO space; FDA experience preferred
Strong working knowledge of SAS and CDISC SDTM and ADaM
Ability to effectively manage multiple tasks and projects
Ability to communicate and explain statistics
Experience preparing budgets/proposals and participating in bid defences
Experience publishing papers or presenting talks at scientific conferences and/or in webinars
Benefits
Interesting and innovative projects
Collaborative and inspirational working environment / atmosphere
Excellent career development and progression opportunities
Work – life balance
Incentive plans, bonuses, and/or other forms of compensation may be offered
Health and welfare and/or other benefits may be offered
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