Senior Manager, Epidemiology Analytics

Onsite in Tarrytown, NY

Summary:

Responsible for statistical programming (primarily SAS), data management, and contribute to Statistical Analysis Plan, sample size and power calculation, and other analytical support to the epidemiological projects on effectiveness and safety evaluation, and other epidemiologic projects that are needed for such as RGC projects using internal or external databases. Work with cross-functional project leaders, scientists, and/or real world data partners to generate real-world data and real-world evidence in support of a wide variety of collaborative projects across the life cycle of the development programs. Conduct statistical analysis and programming activities as a subject matter specialist in epidemiology analytics.

 

Responsibilities:

  • Contribute to the conduct of post-approval real-world efficacy and/or safety studies, or other epidemiological studies related to clinical development and RGC projects, (Development) Risk Management Plans, and safety signal evaluation, include and not limited to preparation of study protocol and study report

 

  • Conduct sample size calculation and statistical power estimate in support of the designs of real-world/non-interventional studies

 

  • Develop statistical analysis plan (SAP), SAS programming, and execute statistical analyses for epidemiological studies and/or the evaluation of causality between treatments and efficacy and safety outcomes

 

  • Develop common analytic frameworks and comprehensive reusable programs foreseeing future need of SAS programming and statistical analysis

 

  • Implement and/or QC SAS programming, statistical analyses, and study results

 

  • Provide support in evaluation, acquisition, storage, management, and maintenance of existing internal databases and/or new databases for epidemiologic projects, and work with IT staff within the company to address related issues

 

  • Provide support in pharmacovigilance, adverse event analyses, and safety signal validation and assessment

 

  • Support orphan drug application and pediatric study plan

 

  • Support presentation of data and study results to internal and external stake holders

 

Requirements:

 

  • Master's degree or PhD in quantitative fields (e.g. statistics, mathematics, biostatistics, epidemiology)

 

  • Major of biostatistics or epidemiology is preferred

 

  • Typically a Master degree with 5+ years/a PhD with 2+ years (or a Master degree with 7+ years/a PhD with 4+ years for Senior Manager) of statistical analysis/SAS programming experience

 

  • Experience with the analyses and management of insurance claims or automated healthcare databases are highly desirable

 

  • Experience with SAS STAT, GRAPH, SQL and Macros is preferred but not required

 

  • Research experience in the pharmaceutical industry or university-based epidemiology program is desirable but not essential

 

  • Up-to-date knowledge of US and international regulatory requirements and ability to apply this knowledge to epidemiological activities.

 

  • Function as a subject matter expert on epidemiology analytics for assigned compounds

 

  • Experience (minimum 5 years) with statistical analysis/SAS programming and demonstrated achievements

 

  • Experience (minimum 3 years) with the analyses and management of automatic healthcare databases (insurance claims or other longitudinal databases) (internal and large external databases) is strongly preferred

 

  • Excellent verbal and writing communication and interpersonal skills