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Associate Director, Epidemiology Analytics

Basking Ridge, NJ 07920

Posted: 01/15/2025 Employment Type: Contract Job Category: Data Sciences Job Number: 616904 Is job remote?: Yes Country: United States

Job Description

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Job Description:

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 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 the evaluation and management of adverse events and risks associated with our pharmaceutical products. We are looking for a detail-oriented, experienced, resilient, and proactive individual with outstanding analytical and communication skills. 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:

· Collaborate with cross-functional teams to evaluate and manage adverse events and risks associated with pharmaceutical products

· Provide data management of diverse data (e.g., real-world setting and clinical trial) to set up epidemiologic data sets for various approaches, quantitative epidemiologic data analysis, interpretation of results, visualization of results, and generate manuscripts to disseminate findings

· Conduct statistical analyses for epidemiological research and safety queries, including but not limited to:

o Descriptive summary and multivariable regression

o Exploratory analysis for safety endpoints in clinical trial data

o Setup and analysis of case-control and cohort study designs

o Signal detection analysis in spontaneous reports (e.g., FAERS, EVDAS)

o Signal detection/evaluation analysis in RWD

o Data mining using the data from ClinicalTrials.gov

o Literature review and meta-analysis

· Maintain compliance with all applicable regulations and guidelines related to pharmacovigilance and drug safety

· Participate in the preparation and submission of regulatory documents related to drug safety

· Collaborate with global epidemiology teams to ensure consistency and quality in safety reporting and processes

· Participate in cross-functional meetings and provide input and guidance as needed

· Stay informed about emerging safety issues and contribute to the development of risk management strategies

· Mentor and provide guidance to junior team members

Skills:

· Proficiency with programming in R, SAS, or Python for data mining and epidemiologic analysis

· Strong written, oral and electronic communication skills

· Excellent leadership skills, with the ability to work effectively in a collaborative team environment

· The ideal candidate will have a strong background in both biostatistics and epidemiology (or other medical fields)

· Travel: Occasional travel may be required (<20%)

Education:
· Ph.D. degree in biostatistics, statistics, epidemiology, or a related field with a minimum of 5 years of experience in epidemiologic methods and data analysis (either in the pharmaceutical industry or academia)

Certifications:
Proficiency with programming in R, SAS, or Python for data mining and epidemiologic


**CO/NY candidates may not be considered 

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma is an equal opportunity employer. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About Basking Ridge, NJ

Discover exciting job opportunities in the vibrant area surrounding Basking Ridge, New Jersey! Known for its picturesque landscapes, rich history, and thriving business community, Basking Ridge offers an unparalleled quality of life for professionals seeking growth and success. With easy access to NYC and iconic landmarks like the historic Jacobus Vanderveer House and the stunning Scherman Hoffman Wildlife Sanctuary, this charming region provides a perfect blend of career prospects and leisure pursuits. Indulge in locally sourced cuisine, catch a show at the elegant Ridge Performing Arts Center, or explore the natural beauty of Lord Stirling Park. Embrace the unique culture and endless possibilities that Basking Ridge has to offer as you explore our latest job listings and embark on a fulfilling career journey in this enchanting area.

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.