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Associate Director, Biostatistics
Gilead Sciences. Provide strategic and operational statistical leadership for clinical development programs within the Virology Therapeutic Area .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates advanced knowledge of biomedical statistical analysis and biostatistics best practices, with a strong ability to design and implement statistical strategies for clinical development programs. Proven leadership in managing statistical activities across clinical trials while adhering to regulatory requirements and industry standards.
Highest-signal resume keywords
Advanced Knowledge Of Biomedical Statistical AnalysisStatistical Analysis Strategy DevelopmentProject Management And Team LeadershipKnowledge Of FDA And EMA RegulationsExperience In Virology
ATS Keywords
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Hard Skills
Statistical Analysis PlansSample Size DeterminationClinical Trial MonitoringBiostatistical InputStatistical Software ProficiencyInnovative Trial DesignsStatistical Methods And TechniquesData AnalysisProtocol DevelopmentBiomarker Analysis
Soft Skills
Strong Written And Verbal CommunicationCollaborationOrganizational Skills
Industry Keywords
Virology Therapeutic AreaClinical DevelopmentGCPICH GuidelinesRegulatory RequirementsStatistical Analysis PrinciplesClinical PharmacologyPatient SafetyClinical Data ManagementSOP Development
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Provide strategic and operational statistical leadership for clinical development programs within the Virology Therapeutic Area
- Serve as lead statistician for Phase 1–3 clinical trials, with responsibility for overall statistical strategy and delivery
- Represent Biostatistics on study management and development teams
- Collaborate with Clinical Development, Patient Safety, Clinical Pharmacology, Regulatory Affairs, Project Management, Programming and Clinical Data Management
- Provide statistical input into study design, clinical development plans, sample size determination and protocol development
- Author statistical analysis plans and review TFLs and clinical study reports
- Oversee and lead technical and operational statistical activities for groups of clinical trials
- Direct internal and external teams in statistical activities for molecules or marketed products
- Advise on statistical analysis strategies, measurement reliability, model identifiability and interpretation of results
- Review and analyze safety reporting, biomarker analyses and clinical trial monitoring data
- Use advanced statistical software, methods and techniques to analyze historical and external data
- Provide biostatistical input into clinical development documentation, scientific publications, presentations and regulatory documentation
- Participate in or lead special projects, innovative methodologies, processes, technology, tools and SOP development
- Adhere to regulatory requirements, statistical analysis principles, industry standards and Gilead SOPs
- Create inclusion, develop talent and empower teams as a people leader
Requirements
What you’ll need- Bachelor's Degree and 10 years’ experience OR Master's Degree and 8 years’ experience OR PhD and 2 years’ experience
- Advanced knowledge of biomedical statistical analysis
- Independence in designing, implementing and managing multiple statistical analysis strategies, plans, deliverables and resource management
- Advanced knowledge of biostatistics best practices and tools
- Understanding of drug development phases and associated clinical trials across phases
- Knowledge of FDA and EMA regulations, ICH guidelines, GCP and standard clinical procedures
- Familiarity with innovative trial designs
- Proven effectiveness managing projects and teams
- Experience in Virology is preferred
- Strong written and verbal communication, collaboration and organizational skills
Benefits
Comp & perks- Discretionary annual bonus
- Discretionary stock-based long-term incentives
- Paid time off
- Company-sponsored medical insurance
- Company-sponsored dental insurance
- Company-sponsored vision insurance
- Company-sponsored life insurance
- Benefits package