Associate Director, Biostatistics (Late Stage Oncology)

Daiichi Sankyo - Basking Ridge, NJ

Hiring: Associate Director, Biostatistics (Late Stage Oncology) Company: Daiichi Sankyo Location: Basking Ridge, NJ Job Posted Time: 2026-09-10 14:01:09 Employment Type: Contract Target Skills & Keywords : SAP About the job Experience: •8+ years of relevant experience in the pharmaceutical industry with a masters degree required •5+ years of relevant experience in the pharmaceutical industry with a PhD preferred Required Skills: •Leads statistical activities for complex studies including study design, protocol development, CRF review, 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 data manager to ensure high quality data. •Drug Development Strategy: Provides input to multiple aspects of the development plan 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 complex 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: •Master's Degree in statistics or biostatistics required •PhD in statistics or biostatistics preferred •Demonstrated capacity to travel up to 10% of the time. •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. Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!