Director of Biostatistics — Bernards Township, NJ at

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 in clinical development, responsible for guiding multiple early-phase compounds or complex studies with minimal supervision. You will act as the statistical expert for assigned projects, providing critical inputs to the overall clinical development plan to ensure it delivers the pre-specified product profile in a logical and scientifically sound manner.

Your day-to-day involves collaborating with global project teams, Health Authorities, and contract research organizations (CROs) to optimize statistical handling through innovative trial designs and modeling. You will work closely with the statistical innovation group, precision medicine biostat group, and real-world data (RWD) group to drive initiatives that harmonize processes and improve drug development efficiency. Beyond technical execution, you will mentor junior statisticians, ensuring high-quality deliverables from protocol development through to the Clinical Study Report (CSR).

Why Join Us

Working at Daiichi Sankyo is more than just a job—it is your chance to make a difference and change patients' lives for the better. We can only achieve this ambitious goal together. That is why we foster a culture of mutual respect and continuous learning, with a strong commitment to inclusion and diversity. Here, you will have the opportunity to grow, think boldly, and contribute your ideas. If you have a proactive mindset and a passion for addressing the needs of patients, we eagerly await your application.

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 design, analysis, and interpretation of early phase compounds and complex studies
check_circleAuthor regulatory documents and responses submitted to global Health Authorities
check_circleGuide project teams in utilizing innovative study designs to maximize drug product success
check_circleMentor junior statisticians on protocol development, analysis plans, and clinical study reports
check_circleLead planning and analysis of integrated efficacy and safety data across assigned projects
check_circleProvide strategic input to clinical development plans to ensure scientific soundness and regulatory compliance
check_circleReview CRO proposals, negotiate timelines, and guide external biostatisticians on data consistency
check_circleDrive initiatives to optimize drug development processes and reduce costs

Requirements

verifiedPhD in statistics or biostatistics
verified7+ years of relevant experience in the pharmaceutical industry
verifiedExpert knowledge of drug development and statistical methodologies
verifiedExcellent programming skills in SAS and/or R
verifiedWorking knowledge of statistical software package such as NQUERY, EAST, etc

Nice to Have

Working knowledge of statistical software package such as NQUERY, EAST, etc.

Skills, education and keywords

Skills: Sas, R, Nquery, East, Drug Development, Statistical Methodologies, Trial Design, Data Analysis, Protocol Development, Statistical Analysis Plan.

Education: PhD in statistics or biostatistics required.

Frequently asked questions about Director, Early Phase Biostatistics (m/f/d) at Daiichi Sankyo US

What does a Director, Early Phase Biostatistics (m/f/d) at Daiichi Sankyo US do?expand_more

Day-to-day, the Director, Early Phase Biostatistics (m/f/d) at Daiichi Sankyo US will lead statistical design, analysis, and interpretation of early phase compounds and complex studies; author regulatory documents and responses submitted to global health authorities; guide project teams in utilizing innovative study designs to maximize drug product success; and mentor junior statisticians on protocol development, analysis plans, and clinical study reports.

What are the requirements for this Director, Early Phase Biostatistics (m/f/d) role?expand_more

To qualify for the Director, Early Phase Biostatistics (m/f/d) at Daiichi Sankyo US position, applicants should have: PhD in statistics or biostatistics; 7+ years of relevant experience in the pharmaceutical industry; Expert knowledge of drug development and statistical methodologies; Excellent programming skills in SAS and/or R; and Working knowledge of statistical software package such as NQUERY, EAST, etc.

Where is the Director, Early Phase Biostatistics (m/f/d) role at Daiichi Sankyo US located?expand_more

Director, Early Phase Biostatistics (m/f/d) 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 Director, Early Phase Biostatistics (m/f/d) job remote, hybrid, or on-site?expand_more

Daiichi Sankyo US has listed this Director, Early Phase Biostatistics (m/f/d) role as on-site.

How much experience is required for this Director, Early Phase Biostatistics (m/f/d) role?expand_more

Director, Early Phase Biostatistics (m/f/d) at Daiichi Sankyo US typically requires 7+ years of relevant experience at the lead level.

What skills do you need for the Director, Early Phase Biostatistics (m/f/d) role at Daiichi Sankyo US?expand_more

Key skills for Director, Early Phase Biostatistics (m/f/d) at Daiichi Sankyo US include Sas; R; Nquery; East; Drug Development; Statistical Methodologies; Trial Design; and Data Analysis.

What education is required for Director, Early Phase Biostatistics (m/f/d) at Daiichi Sankyo US?expand_more

Educational requirements for this role: PhD in statistics or biostatistics required.

What category does the Director, Early Phase Biostatistics (m/f/d) role belong to?expand_more

Director, Early Phase Biostatistics (m/f/d) at Daiichi Sankyo US is part of the scientific & qa job category on Recrutus.

Director, Early Phase Biostatistics (m/f/d)