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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in statistical methods and safety evaluation within the Oncology Therapeutic Area, with a strong focus on regulatory compliance and cross-functional collaboration. Proficient in leading safety monitoring initiatives and developing innovative statistical tools to support clinical safety projects.
Highest-signal resume keywords
PhD In Statistics Or BiostatisticsStatistical Methods ExpertiseSAS Or R ProficiencyRegulatory Requirements KnowledgeClinical Trial Design Experience
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 MethodsSurvival AnalysisMeta-AnalysisBayesian MethodsMatchingPropensity Score AnalysisIntegrated Safety Data AnalysisRandomized Clinical Trial MethodsNonrandomized Clinical Trial MethodsReal-World Data Analysis
Soft Skills
Strong Communication SkillsProject Management SkillsLeadership SkillsInfluencing Cross-Functional Teams
Industry Keywords
Oncology Therapeutic AreaClinical Safety StatisticsRisk Management Safety TeamsSafety EvaluationsDrug Development ProcessAI Tools In Drug DevelopmentBenefit-Risk AssessmentAggregate Safety Evaluations
About the role
Key responsibilities & impact- Lead safety monitoring and evaluation within Clinical Safety Statistics for key Oncology Therapeutic Area programs
- Provide statistical leadership and support to Risk Management Safety Teams in planning and executing compound-level safety evaluations throughout the product life cycle
- Design, develop, and implement innovative statistical methods and tools for safety evaluation
- Provide statistical leadership for compound safety evaluation strategies and analyses in Oncology
- Support Clinical Safety Statistics projects in other therapeutic areas as needed
- Partner with Clinical Safety Risk Management, Development Statistics, Epidemiology, Programming, and other Risk Management Safety Team functions
- Plan and conduct aggregate safety evaluations for oncology projects
- Ensure safety deliverables meet analysis requirements, applicable SOPs, and regulatory guidance
- Communicate safety analysis results and recommendations to cross-functional teams, management, regulators, and investigators
- Develop processes, job aids, statistical methods, and tools for safety evaluation addressing scientific and business needs
Requirements
What you’ll need- PhD or equivalent degree in statistics, biostatistics, or a related discipline with at least 6 years of relevant work experience, or a master’s degree with at least 9 years of relevant work experience
- Strong knowledge of statistical methods, including survival analysis, meta-analysis, Bayesian methods, matching, and propensity score analysis
- Proficiency in statistical software such as SAS or R
- Strong knowledge of regulatory requirements for analyzing and reporting safety data
- Knowledge and experience in clinical trial design and analysis, including integrated safety data
- Knowledge of statistical methods for randomized and nonrandomized clinical trial and real-world data
- Strong communication, project management, and leadership skills
- Ability to influence cross-functional teams and align priorities across the therapeutic area
- Preferred: knowledge of the drug and vaccine development process
- Preferred: interest or publications involving novel statistical methods for safety data monitoring, evaluation, and benefit-risk assessment
- Preferred: knowledge and experience developing or applying AI tools in drug development projects
- Preferred: understanding of disease biology
- US and Puerto Rico residents only
- Visa sponsorship is not available
- Valid driving license is not required
Benefits
Comp & perks- Annual bonus
- Long-term incentive, if applicable
- Medical, dental, and vision healthcare
- Other insurance benefits for employee and family
- Retirement benefits, including 401(k)
- Paid holidays
- Vacation days
- Compassionate days
- Sick days
- Hybrid work arrangement