Associate Director, Biostatistics – Oncology Position Available In Somerset, New Jersey

Job Description:

Join a Legacy of Innovation 125 Years and Counting! DaiichiSankyo Group is dedicated to the creation and supply of innovativepharmaceutical therapies to improve standards of care and addressdiversified, unmet medical needs of people globally by leveragingour world-class science and technology. With more than 125 years ofscientific expertise and a presence in more than 20 countries,Daiichi Sankyo and its 18,000 employees around the world draw upona rich legacy of innovation and a robust pipeline of promising newmedicines to help people. In addition to a strong portfolio ofmedicines for cardiovascular diseases, under the Group’s 2025Vision to become a “Global Pharma Innovator with CompetitiveAdvantage in Oncology,” Daiichi Sankyo is primarily focused onproviding novel therapies in oncology, as well as other researchareas centered around rare diseases and immune disorders.

JobSummary:

Position leads complex studies in study design,statistical analysis and interpretation of results with somesupervision. This position contributes to specific aspects of drugdevelopment plans with minimal supervision and contributes todocuments submitted to Health Authorities globally with somesupervision. This position also guides contract researchorganization (CRO) programmers and statisticians in preparinganalysis files and performing statistical analyses. Additionally,this position interacts with study teams, as well as statisticiansand programmers at CROs. This position works under some supervisionto solve complex study problems.

Responsibilities:

ProtocolDevelopment, Case Report Form (CRF; review), Statistical AnalysisPlan (SAP), Statistical Analysis, Results Interpretation, andclinical study report (CSR): Leads statistical activities forcomplex studies including study design, protocol development, CRFreview, SAP development, analysis files development, statisticalanalysis accuracy validation, results interpretation and CSR inputand review. Acts as main statistical contact for the assignedstudies and projects. Provides guidance to study team on allaspects of statistical activities; collaborates closely with datamanager to ensure high quality data.

Drug Development Strategy:

Provides input to multiple aspects of the development plan toensure the study designs at each phase of the development arescientifically sound, can fulfill regulatory requirements anddeliver the pre-specified product profile. CRO /

Vendor Oversight:

Review CRO/vendor proposal and budget. Establishes proceduresthrough regular interaction, setting expectation on deliverablesand timelines to guide CRO biostatistician and statisticalprogrammers on complex studies. Ensures deliverables are accurateand delivered according to the timelines. Global Health AuthorityInteraction /

Negotiation:

Contributes to documents submitted toHealth Authorities globally by providing input for the interactionor by writing the interaction document. May participate in meetingor teleconferences with Health Authorities Global BDO Strategy to

Improve Drug Development:

Primarily participates and mayoccasionally lead moderately complex initiatives, with some levelof supervision, to improve the harmonization and efficiency of drugdevelopment which leads to cost savings and shortened timelines forthe company.

Qualifications:

Successful candidates will be able tomeet the qualifications below with or without a reasonableaccommodation.

Education:

Master’s Degree in statistics orbiostatistics required PhD in statistics or biostatistics preferredexperience

Qualifications:

8 Years of relevant experience in thepharmaceutical industry with a master’s degree required 5 Years ofrelevant experience in the pharmaceutical industry with a

PhDpreferred Travel:

Ability to travel up to 10% Daiichi Sankyo, Inc.is an equal opportunity/affirmative action employer. Qualifiedapplicants will receive consideration for employment without regardto sex, gender identity, sexual orientation, race, color, religion,national origin, disability, protected veteran status, age, or anyother characteristic protected by law.