Epidemiology Analytics Lead, Drug Safety

Daiichi Sankyo US; Basking Ridge (NJ); On-site; USD 157,920 - 236,880; Full time

Job summary

Daiichi Sankyo US seeks an Associate Director in Epidemiology Analytics to drive safety evidence using trial and real-world data. You will lead analysis plans for signal detection, risk-benefit assessments, and regulatory support with cross-functional stakeholders.

The role requires collaboration with statisticians, epidemiologists, and CSPV teams, plus mentoring junior staff and ensuring pharmacovigilance compliance across projects.

Qualifications

• Master's degree plus 7 years epidemiologic data analysis required.
• PhD with 4 years epidemiologic data analysis preferred.
• Industry experience in safety or related service provider preferred.

Responsibilities

• Descriptive summary and multivariable regression.
• Exploratory safety endpoint analyses in trial data.
• Design and analyze case-control and cohort studies.
• Signal detection in spontaneous reports (FAERS, EVDAS).
• Analyze signals in real-world data.
• Data mining including free-text mining.
• Develop automation platforms (e.g., R Shiny).
• Literature review and meta-analysis.
• Collaborate with cross-functional teams on safety.
• Prepare regulatory documents related to drug safety.
• Maintain project plans and deliverables on time.
• Coordinate with global epidemiology teams for consistent safety reporting.
• Mentor junior team members.

Skills

R programming

SAS

SQL

Python

Epidemiology

Education

Master's Degree in Biostatistics/Data Science/Statistics/Epidemiology or related field

PhD in Biostatistics/Data Science/Statistics/Epidemiology or related field

Tools

R Shiny

Job description

Daiichi Sankyo US seeks an Associate Director in Epidemiology Analytics to drive safety evidence using trial and real-world data. You will lead analysis plans for signal detection, risk-benefit assessments, and regulatory support with cross-functional stakeholders.

The role requires collaboration with statisticians, epidemiologists, and CSPV teams, plus mentoring junior staff and ensuring pharmacovigilance compliance across projects.