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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 biostatistics and statistical analysis strategies, with a strong focus on clinical development and regulatory compliance. Proven ability to lead teams, manage projects, and collaborate effectively across various clinical and operational functions.
Highest-signal resume keywords
Advanced Knowledge Of Biomedical Statistical AnalysisExperience With Advanced Statistical SoftwareUnderstanding Of Drug Development PhasesKnowledge Of FDA And EMA RegulationsProven Effectiveness Managing Projects And Teams
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Statistical Analysis StrategiesBiostatistics Best PracticesSample Size DeterminationStatistical Analysis PlansClinical Trial MonitoringBiomarker AnalysesStatistical SoftwareInnovative Trial DesignsProtocol DevelopmentData Analysis Techniques
Soft Skills
Strong Written CommunicationStrong Verbal CommunicationCollaboration SkillsOrganizational SkillsPeople Leadership
Industry Keywords
Virology Therapeutic AreaClinical DevelopmentRegulatory AffairsICH GuidelinesGCPClinical Data ManagementStatistical Analysis PrinciplesGilead SOPsClinical ProceduresSafety Reporting
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
- Represent Biostatistics on study management teams 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 tables, figures, listings, 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 and presentation of results
- Review and analyze safety reporting, biomarker analyses, and clinical trial monitoring data
- Use advanced statistical software and methods 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
- 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, and GCP
- Familiarity with standard clinical procedures
- Experience with advanced statistical software, methods, and techniques
- Strong written and verbal communication, collaboration, and organizational skills
- Experience in Virology is preferred
- Familiarity with innovative trial designs
- Proven effectiveness managing projects and teams
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
- Reasonable accommodation for applicants protected under applicable laws