Associate Director, Biostatistics-Medical Affairs/RWE in Basking Ridge, NJ at DSI

Date Posted: 4/11/2021

Job Snapshot

Job Description

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:

This position leads medical affairs and observational studies in study design, statistical analysis, interpretation of results with some supervision, and publications. This position also collaborates with contract research organization (CRO) statistician as needed or guides CRO programmers in preparing analysis files and performing statistical analyses. Additionally, this position interacts with study teams to provide necessary project deliverables.

Responsibilities:

Protocol Development, Case Report Form (CRF; review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for studies including study design, protocol development, CRF review (as applicable to the study), SAP development, analysis files development, statistical analysis accuracy validation, results interpretation and CSR input and review. Acts as main statistical contact for the assigned studies and projects. Work closely with internal/CRO statistical programmers

Medical Affairs and Observational Studies: Provides guidance in scientific and statistical aspects of medical affairs studies and support publications to ensure the quality. Also responsible for the statistical planning and execution of Real-World Evidence activities. Work effectively with the study team to support and provide the study deliverables.

CRO / Vendor Oversight: Review CRO/vendor proposal and budget. Establishes procedures through regular interaction, setting expectation on deliverables and timelines to guide CRO biostatistician and statistical programmers on complex studies. Ensures deliverables are accurate and delivered according to the timelines.

Global Health Authority Interaction: Contributes to documents submitted to Health Authorities globally (e.g. HTA) by providing input for the interaction or by writing the interaction document.

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

Education/Experience:

PhD in statistics or biostatistics or Master’s in Statistics/Biostatistics. Ph.D. strongly preferred.

Minimum 5 years relevant experience in the pharmaceutical industry with Ph.D. or 7 years with Masters.

Good understanding of statistical methodologies, regulatory requirements, clinical trials and observational studies.

Experience on statistical software (e.g. SAS, R) and secondary data sources including registries, EMR and claims is an advantage.

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.