Associate Director Biostatistics — Bernards Township

About Daiichi Sankyo

At Daiichi Sankyo, we are united by a single purpose: to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and over 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders.

Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society," we are shaping a healthier, more hopeful future for patients, their families, and society.

About the Role

This position serves as a strategic leader for complex clinical studies, bridging the gap between scientific design and regulatory execution. You will drive the statistical integrity of drug development plans, ensuring that study designs are scientifically sound and capable of fulfilling global regulatory requirements.

In this role, you will act as the primary statistical contact for assigned projects, guiding contract research organization (CRO) programmers and statisticians through the preparation of analysis files and the execution of complex statistical analyses. Your work involves solving intricate study problems under varying levels of supervision, collaborating closely with data managers to ensure high-quality data, and providing critical input to documents submitted to Health Authorities globally. You will also lead initiatives to harmonize and improve the efficiency of drug development, directly contributing to cost savings and shortened timelines.

Equal Opportunity

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.

Work location

Work model: On-site

316, Lyons Road, Liberty Corner, Bernards Township, Somerset County, New Jersey, 07920, United States

Bernards Township, New Jersey

Key Responsibilities

check_circleLead statistical activities for complex studies including study design and protocol development
check_circlePerform statistical analysis accuracy validation and interpret study results
check_circleProvide guidance to study teams and collaborate with data managers to ensure high quality data
check_circleGuide CRO biostatisticians and programmers on complex study analysis and timelines
check_circleContribute to documents submitted to global Health Authorities and participate in interactions
check_circleReview and develop Case Report Forms (CRF) and Statistical Analysis Plans (SAP)
check_circleLead initiatives to improve drug development harmonization, efficiency, and cost savings
check_circleReview CRO vendor proposals and budgets while establishing procedures for deliverables

Requirements

verifiedMaster's Degree in statistics or biostatistics required
verifiedPhD in statistics or biostatistics preferred
verified8+ Years of relevant experience in the pharmaceutical industry with a masters degree required
verified5+ Years of relevant experience in the pharmaceutical industry with a PhD preferred
verifiedAbility to travel up to 10% of the time

Nice to Have

PhD in statistics or biostatistics

Benefits & Perks

check_circleDownload Our Benefits Summary PDF

Skills, education and keywords

Skills: Study Design, Statistical Analysis, Protocol Development, Case Report Form, Statistical Analysis Plan, Clinical Study Report, Drug Development, Cros, Biostatistician, Statistical Programmers.

Education: Master's Degree in statistics or biostatistics required; PhD in statistics or biostatistics preferred.

Frequently asked questions about Associate Director, Biostatistics (Late Stage) at Daiichi Sankyo US

What does a Associate Director, Biostatistics (Late Stage) at Daiichi Sankyo US do?expand_more

Day-to-day, the Associate Director, Biostatistics (Late Stage) at Daiichi Sankyo US will lead statistical activities for complex studies including study design and protocol development; perform statistical analysis accuracy validation and interpret study results; provide guidance to study teams and collaborate with data managers to ensure high quality data; and guide cro biostatisticians and programmers on complex study analysis and timelines.

What are the requirements for this Associate Director, Biostatistics (Late Stage) role?expand_more

Daiichi Sankyo US is looking for candidates who meet the following requirements: Master's Degree in statistics or biostatistics required; PhD in statistics or biostatistics preferred; 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; and Ability to travel up to 10% of the time.

Where is the Associate Director, Biostatistics (Late Stage) role at Daiichi Sankyo US located?expand_more

Associate Director, Biostatistics (Late Stage) at Daiichi Sankyo US is based in 316, Lyons Road, Liberty Corner, Bernards Township, Somerset County, New Jersey, 07920, United States. This is a on-site role.

Is this Associate Director, Biostatistics (Late Stage) job remote, hybrid, or on-site?expand_more

Daiichi Sankyo US has listed this Associate Director, Biostatistics (Late Stage) role as on-site.

How much experience is required for this Associate Director, Biostatistics (Late Stage) role?expand_more

Associate Director, Biostatistics (Late Stage) at Daiichi Sankyo US typically requires 8+ years of relevant experience at the lead level.

What skills do you need for the Associate Director, Biostatistics (Late Stage) role at Daiichi Sankyo US?expand_more

Key skills for Associate Director, Biostatistics (Late Stage) at Daiichi Sankyo US include Study Design; Statistical Analysis; Protocol Development; Case Report Form; Statistical Analysis Plan; Clinical Study Report; Drug Development; and Cros.

What education is required for Associate Director, Biostatistics (Late Stage) at Daiichi Sankyo US?expand_more

Educational requirements for this role: Master's Degree in statistics or biostatistics required; and PhD in statistics or biostatistics preferred.

What category does the Associate Director, Biostatistics (Late Stage) role belong to?expand_more

Associate Director, Biostatistics (Late Stage) at Daiichi Sankyo US is part of the healthcare & nursing job category on Recrutus.

Associate Director, Biostatistics (Late Stage)