Associate Director, Epidemiology Analytics

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

At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society.

Job Summary

This position of Associate Director has responsibilities as a safety data scientist in Epidemiology Analytics group of Clinical Safety and Pharmacovigilance (CSPV) at Daiichi Sankyo. This position uses and analyzes both clinical trial data and real-world data (RWD) to support our products under the supervision of the head of Epidemiology Analytics. This position leads the development and implementation of statistical analysis plan to support signal detection and evaluation, risk-benefit assessment, and other drug safety evaluation activities. This position collaborates with internal and external stakeholders including statisticians, epidemiologists, clinical safety and pharmacovigilance, regulatory, clinical, and other project stakeholders. In this position, you will play a critical role in supporting Epidemiologist and Safety Science team during an evaluation of adverse events and assessment of potential risks associated with our pharmaceutical products. We are looking for a detail-oriented, experienced, resilient, and proactive individual with outstanding analytical and communication skills in the industry or service provider settings. If you are driven by a desire to make a positive impact on the enrichment of quality of life around the world, we encourage you to apply for this exciting opportunity.

Responsibilities

• Descriptive summary and multivariable regression
• Exploratory analysis for safety endpoints in clinical trial data
• Setup and analysis of case-control and cohort study designs
• Signal detection analysis in spontaneous reports (e.g., FAERS, EVDAS)
• Signal detection/evaluation analysis in RWD
• Data mining (including free-text mining of unstructured data fields) using diverse data sources and methods
• Development of automation platform (e.g., R Shiny App)
• Literature review and meta-analysis
• Collaborate with cross-functional teams to evaluate and manage adverse events and risks associated with pharmaceutical products
• Participate in cross-functional meetings and provide input and guidance as needed
• Participate in the preparation and submission of regulatory documents related to drug safety
• Maintain and manage project plans to provide deliverables on time
• Collaborate with global epidemiology teams to ensure consistency and quality in safety reporting and processes
• Maintain compliance with all applicable regulations and guidelines related to pharmacovigilance and drug safety
• Stay informed about emerging safety issues and contribute to the development of risk management strategies
• Mentor and provide guidance to junior team members

Qualifications

Education Qualifications

Master's Degree in Biostatistics, Data Science, Statistics, Applied Mathematics, Epidemiology, or related field plus 7 years of experience in epidemiologic methods and data analysis (pharmaceutical industry in safety or associated service provider experience is preferred) required. PhD in Biostatistics, Data Science, Statistics, Applied Mathematics, Epidemiology, or related field plus 4 years of experience in epidemiologic methods and data analysis (pharmaceutical industry in safety or associated service provider experience is preferred) preferred.

Experience Qualifications

3 or more years of professional experience within the pharmaceutical industry

Demonstrated professional statistician skills and expertise

Proven experience leading large and/or complex statistical programming projects preferred

Experience providing technical and/or programming guidance and mentoring to junior programmers, fellows and team members.

Ability and interest to work across cultures and geographies

Ability to adapt to change and seamlessly assimilate to new projects and stakeholders

Experience developing statistical analysis plan and Meta Data Repositories

Familiarity with data management concepts of non-interventional studies

Strategic thinking

Demonstrate proficiency with programming in R, SAS, SQL, and/or Python for data mining and epidemiologic analysis

Travel Requirements

Ability to travel up to 20% of the time. Both domestic and occasional travel may be required

Additional Information

Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Salary Range

USD$157,920.00 - USD$236,880.00