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Senior Manager, Biostatistics
Gilead Sciences. Provide strategic and operational statistical leadership for clinical development programs within the Inflammation Therapeutic Area .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in statistical leadership for clinical development programs, including study design, statistical analysis planning, and regulatory compliance. Proven ability to lead teams, communicate effectively, and oversee operational statistical activities across multifunctional areas.
Highest-signal resume keywords
Statistical Leadership ExperienceStudy Design ExpertiseStatistical Analysis PlanningProtocol DevelopmentTeam Leadership
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
Statistical PlanningData AnalysisSample Size DeterminationSAP AuthoringTFL ReviewCSR ReviewScientific PublicationRegulatory RequestsClinical Development PlansInterpreting Statistical Data
Soft Skills
Excellent Communication SkillsInterpersonal SkillsTeam BuildingLeadershipEffective Scientific Communication
Industry Keywords
Clinical DevelopmentBiostatisticsInflammation Therapeutic AreaClinical TrialsRegulatory AffairsProject ManagementClinical Data ManagementStatistical ProgrammingVirology Data AnalysisCase Report Forms
About the role
Key responsibilities & impact- Provide strategic and operational statistical leadership for clinical development programs within the Inflammation Therapeutic Area
- Represent Biostatistics on study management teams and development teams for multiple studies or programs
- Collaborate with Clinical Development, Patient Safety, Clinical Pharmacology, Regulatory Affairs, Project Management, Programming, and Clinical Data Management
- Provide statistical strategic input into study design, clinical development plans, sample size determination, and protocol development
- Author statistical analysis plans (SAPs)
- Review tables, figures, and listings (TFLs) and clinical study reports (CSRs)
- Provide biostatistical input into scientific publications, presentations, and regulatory requests
- Lead or contribute to non-molecule-based department strategic initiatives and working groups
- Collaborate with Statistical Programmers, Biostatisticians, Clinical Research Associates, Clinical Data Managers, Clinical, Global Drug Safety, Regulatory, and Project Management staff
- Direct internal and external teams across multifunctional project or functional areas
- Lead initiatives to gather, organize, and analyze data from virology, Case Report Forms, and patient tracking
- Work with management and Human Resources to satisfy short-term staffing needs
- Defend statistical aspects with regulatory agencies
- Develop staff capabilities and recognize/reward desired performance
- Oversee and contribute to all technical and operational statistical activities for groups of clinical trials
- Lead two or more components of departmental strategic initiatives
- Create inclusion, develop talent, and empower teams
Requirements
What you’ll need- Bachelor's degree with 8 years of experience, Master's degree with 6 years of experience, or PhD with 0 years of experience
- Excellent verbal and written communication skills and interpersonal skills
- Proven ability to determine functions most critical to company success and support priorities within the functional area
- Proven ability to pull together and lead highly effective teams and create a clear sense of direction
- Proven ability to design and use available vehicles for effective scientific communication within and outside the company
- Must be able to directly supervise personnel
- Statistical leadership experience in clinical development programs
- Experience with statistical planning, analysis, interpretation, and reporting
- Experience with study design, clinical development plans, sample size determination, protocol development, SAP authoring, TFLs, CSR review, scientific publications and presentations, and regulatory requests
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