Senior Manager, Biostatistics – Oncology
Gilead Sciences
full-time
Posted on:
Location Type: Hybrid
Location: Parsippany • California, New Jersey • 🇺🇸 United States
Visit company websiteSalary
💰 $153,935 - $219,120 per year
Job Level
Senior
Tech Stack
Google Cloud Platform
About the role
- Lead biostatistical analysis and reporting, document review and data inclusion for NDA submissions of assigned studies by collaborating with cross-functional partners
- Provide statistical consultation on clinical development plans, clinical trial design and clinical study endpoints
- Calculate sample size, authoring statistical analysis plans and provide biostatistical input into clinical development documentation, scientific publications and presentations, and regulatory filings
- Oversee and contribute to completion of all technical and operational statistical activities for a group of clinical trials
- Direct internal and external teams in the definition, execution and completion of statistical activities for one or more molecules or marketed products of increasing complexity
- Participate in cross-functional clinical development planning and protocol design and review discussions
- Advise internal and external partners on statistical analysis strategies, reliability of measurements and interpretation of statistical results
- Gather, organize and analyze different data sources to enable delivery of special projects and / or the statistical analysis plan and clinical study endpoints for assigned products
- Review and analyze safety reporting, biomarker analyses and other aspects of clinical trial monitoring
- Use advanced statistical software, methods, and techniques to analyze and interpret research data
- Plan and document computer data file structure; develop, program, manage, and maintain statistical databases; perform or supervise data entry
- Develop enhancements to statistical software, as appropriate, and maintain knowledge of current and emerging trends in statistical analysis methodologies and tools.
Requirements
- Bachelor’s degree and 8 years of experience OR Master’s degree and 6 years of experience OR PhD/ PharmD and 2 years of experience
- PhD in biostatistics or related discipline with relevant experience in statistical analysis of biomedical data using SAS software in the biopharma industry, healthcare, consulting, academia or a related environment
- PhD with 4+ years’ biostatistics experience is preferred
- MS in biostatistics or related discipline with 6+ years’ relevant experience in statistical analysis of biomedical data using SAS software
- Multiple years’ biostatistics or related experience, including experience effectively leading small projects and project teams.
- Significant biomedical statistical analysis experience and experience working with relevant software.
- Experience developing software and other tools to support statistical analysis of biomedical or related data.
- Strong proficiencies in software and other tools used typically used by Biostatistics.
- Proven effectiveness managing projects and teams.
- Demonstrated ability to be a fast learner.
- Demonstrated ability to be flexible and adaptable to change, to move between projects easily and provide support/expertise where needed.
- Advanced knowledge of underlying statistical principles, concepts, practices, standards, processes and tools.
- Advanced knowledge of biostatistics best practices and tools and ability to apply this to improve overall results.
- Strategic thinking in advising others on statistical requirements and opportunities to improve study or other project outcomes.
- Knowledge of FDA and EMA regulations, ICH guidelines, GCP and familiarity with standard clinical procedures.
- Strong communication and organizational skills.
Benefits
- company-sponsored medical, dental, vision, and life insurance plans
- discretionary annual bonus
- discretionary stock-based long-term incentives (eligibility may vary based on role)
- paid time off
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
biostatistical analysisstatistical consultationsample size calculationstatistical analysis plansdata analysisbiomedical statistical analysisproject managementstatistical software developmentstatistical methodologiesclinical trial design
Soft skills
leadershipcommunicationorganizational skillsstrategic thinkingflexibilityadaptabilityteam managementproblem-solvingcollaborationfast learner
Certifications
PhD in biostatisticsMaster's degree in biostatisticsBachelor's degree in related discipline