Associate Director Epidemiology Analytics

Location
Basking Ridge, NJ, United States
Posted
Jun 04, 2021
Ref
10879BR
Hotbed
Pharm Country
Required Education
Bachelors Degree
Position Type
Full time
Join a Legacy of Innovation 110 Years and Counting!

Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.

Job Summary:

The Associate Director, Epidemiology Analytics, uses and analyze big data and real-world data to support DSI products. This position is responsible of data management, programming and statistical analysis under the direction of a Director/Sr Dir Biostatistician. This position leads the statistical programming activities for the creation of study data tabulation model (SDTM) and analysis data model (ADaM) deliverables for analysis and reporting. This position collaborates with internal and external stakeholders including statisticians, epidemiologists, clinical safety and pharmacovigilance, regulatory, clinical, and other project stakeholders.

This position reviews the quality of data from various sources using deep scientific knowledge, programming, and statistical analysis.
This position proactively creates specifications for databases, table shells, programming to support the analysis of important safety topics and identified risks. This position may serve as primary author for programs and statistical analysis plans. This position manages large databases and supervises junior manager scientist or fellows.

Responsibilities:

Reviews and provides expert input to data management, eCRF specs, and other data management documents. Manage project timelines and schedules of specific phases of projects with internal personnel and external vendors. Leads the creation and validation of global macros or systems that streamline repetitive operations to increase programming efficiency.

Creates and validates Case Report Tabulation (SDTM), analysis data model (ADaM) and study data deliverables (SDTM dataset, Define.XML, SDRG, aCRF, ADaM, ADRG), common data model for real world data, collaborating and consulting with project teams, outreach to external vendors and partners, and keeping current with industry submission data standards.

Maintains and manages project plans to provide deliverables on time.

Manage and link large databases such as Claims database, Electronic medical records (EMR), Electronic health record (EHR)

Creates effective SDTM and ADaM deliverables for Analysis and Reporting (A&R) and submission, utilizing global and TA transformation standards

Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

Education/Experience:

Bachelor's Degree in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus a minimum of 7 years SAS programming experience in both, clinical trial and non-interventional studies required

Master's Degree in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 5 or more years SAS programming experience in both, clinical trials and non-interventional studies preferred

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.

Job Title
Associate Director Epidemiology Analytics

City
Basking Ridge

Functional Area
CSPV

State
New Jersey