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Associate Director, Biostatistics – Translational Medicine

Employer
Daiichi Sankyo
Location
Basking Ridge, NJ
Start date
Oct 24, 2021

View more

Discipline
Science/R&D, Biostatistics
Required Education
Doctorate/PHD/MD
Position Type
Contract
Hotbed
Pharm Country

Job Details

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:

Position leads statistical effort in Translational research and Companion Diagnostic (CDx) related study design, statistical analysis and interpretation of results with some supervision.  This position contributes to specific aspects of drug development plans with minimal supervision and contributes to documents submitted to Health Authorities globally with some supervision.  This position also guides contract research organization (CRO) programmers and statisticians in preparing analysis files and performing statistical analyses.  Additionally, this position interacts with study teams, as well as statisticians and programmers at CROs.  This position works under some supervision to solve complex study problems.

Responsibilities:

Protocol Development, Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, clinical study report (CSR), and exploratory statistical analysis support on translational research: Leads statistical activities for Translational research and CDx related studies including study design, protocol development, 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.  Provides guidance to study team on all aspects of statistical activities; collaborates closely with translational medicine group, CDx group and data manager to ensure high quality data.  

CDx and Translational Research Development Strategy: Provides input to multiple aspects of CDx and Translational research development to ensure the study designs at each phase of the development are scientifically sound, can fulfill regulatory requirements and deliver the pre-specified product profile.

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 CDx studies.  Ensures deliverables are accurate and delivered according to the timelines. 

Global Health Authority Interaction / Negotiation: Contributes to documents submitted to Health Authorities globally by providing input for the interaction or by writing the interaction document. May participate in meeting or teleconferences with Health Authorities.

Global BDO Strategy to Improve Drug Development: Primarily participates and may occasionally lead moderately complex initiatives, with some level of supervision, to improve the harmonization and efficiency of drug development which leads to cost savings and shortened timelines for the company.

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

Education/Experience:

PhD in statistics or biostatistics preferred

Minimum 5 years’ relevant experience in the pharmaceutical industry

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.

Company

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.

For more information, please visit: www.daiichisankyo.com.

Daiichi Sankyo, Inc., headquartered in Basking Ridge, New Jersey, is a member of the Daiichi Sankyo Group. To learn more about Daiichi Sankyo, Inc., please visit www.dsi.com.

STOCK EXCHANGE: Tokyo Stock Exchange

STOCK SYMBOL: 4568

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Company info
Website
Phone
(908) 992-6400
Location
211 Mt. Airy Road
Basking Ridge
New Jersey
07920
United States

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