Senior Principal Scientist, Oncology Safety & Statistics

HireLifeScience; Rahway (NJ); Hybrid; USD 191,000 - 300,000; Full time

Benefits offered by this job

Medical, dental, vision coverage

401(k) retirement plan

Paid holidays, vacation, sick days

Hybrid work arrangement

Job summary

Merck & Co., Inc. in Rahway, NJ is seeking a lead statistician within the Clinical Safety Statistics group to drive safety evaluations for oncology programs.

You will partner across functions to plan and execute aggregate safety analyses, ensuring regulatory compliance and clear communication of results. The role requires deep expertise in survival analysis, meta-analysis, Bayesian methods, and real-world data analyses, with strong leadership and collaboration skills.

Qualifications

• PhD or equivalent degree in statistics/biostatistics or 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 regulatory requirements for analyzing and reporting safety data.
• Knowledge of clinical trial design and analysis, including the analysis and interpretation of integrated safety data.

Responsibilities

• Provide statistical leadership for compound safety evaluation strategies and analyses in the Oncology Therapeutic Area; support CSS projects in other therapeutic areas as needed.
• Partner with Clinical Safety Risk Management, Early and Late Development Statistics, Epidemiology, Programming, and other RMST functions to plan and conduct aggregate safety evaluations for oncology projects.
• Ensure that 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 that address scientific and business needs.

Skills

Survival analysis

Meta-analysis

Bayesian methods

Propensity score

SAS

R

Clinical trial design

Regulatory knowledge

Leadership

Communication

Education

PhD or equivalent in statistics/biostatistics or related

Tools

SAS

R

Job description

Merck & Co., Inc. in Rahway, NJ is seeking a lead statistician within the Clinical Safety Statistics group to drive safety evaluations for oncology programs.

You will partner across functions to plan and execute aggregate safety analyses, ensuring regulatory compliance and clear communication of results. The role requires deep expertise in survival analysis, meta-analysis, Bayesian methods, and real-world data analyses, with strong leadership and collaboration skills.