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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, with a strong focus on study design, protocol development, and regulatory compliance. Proven ability to lead teams, develop talent, and effectively communicate scientific information.
Highest-signal resume keywords
Statistical ExpertiseClinical Development ProgramsStudy DesignTeam LeadershipRegulatory Compliance
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 AnalysisSample Size DeterminationProtocol DevelopmentSAP AuthoringTFLsCSR ReviewScientific PublicationsData AnalysisClinical TrialsVirology Data Management
Soft Skills
Excellent Communication SkillsInterpersonal SkillsTeam BuildingStrategic ThinkingLeadership
Industry Keywords
Inflammation Therapeutic AreaClinical ResearchRegulatory AffairsProject ManagementClinical Data Management
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, protocol development, SAP authoring, TFLs, CSR review, scientific publications and presentations, and regulatory requests
- Lead or contribute to non-molecule-based activities such as department strategic initiatives and working groups
- Work collaboratively with Statistical Programmers, Biostatisticians, Clinical Research Associates, Clinical Data Managers, Clinical staff, 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 technical and operational statistical activities for groups of clinical trials through management of internal and external resources
- Lead two or more components of departmental strategic initiatives
- Create inclusion, develop talent, and empower teams as a people leader
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 lead highly effective teams and create a clear sense of direction
- Proven ability to design and use vehicles for effective scientific communication within and outside the company
- Must be able to directly supervise personnel
- Ability to lead or contribute to departmental strategic initiatives
- Experience with clinical development programs and clinical trials
- Statistical expertise in 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 eligibility
- Discretionary stock-based long-term incentives eligibility may vary based on role
- Paid time off
- Company-sponsored medical insurance
- Company-sponsored dental insurance
- Company-sponsored vision insurance
- Company-sponsored life insurance
- Benefits package
- Reasonable accommodation for individuals protected under applicable law