Director, Early Phase Biostatistics
Not Disclosed•Full-TimeOn-site
location_on316, Lyons Road, Liberty Corner, Bernards Township, Somerset County, New Jersey, 07920, United States
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 within our clinical development team, responsible for guiding multiple early-phase compounds or complex studies. You will operate with minimal supervision to drive the statistical design, analysis, and interpretation of results, ensuring they align with the overall clinical development plan.
In this role, you will act as a statistical expert, providing critical inputs to drug development strategies that are logical, scientifically sound, and compliant with global regulatory requirements. You will collaborate closely with global project teams, Health Authorities, and external partners, including CRO programmers and statisticians. Your work involves utilizing innovative trial designs and modeling to optimize statistical handling, often in collaboration with our statistical innovation, precision medicine, and real-world data groups.
Beyond technical execution, you will mentor junior statisticians, guiding them through protocol development, analysis planning, and result interpretation to ensure high-quality deliverables. You will also play a key role in vendor management, negotiating timelines and ensuring consistency in data definitions and methodologies across CRO partners.
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
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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 at Daiichi Sankyo US
What does a Director, Early Phase Biostatistics at Daiichi Sankyo US do?expand_more
A Director, Early Phase Biostatistics at Daiichi Sankyo US is responsible for the following: Lead statistical design, analysis, and interpretation of early phase compounds and complex studies; Author regulatory documents and responses submitted to global Health Authorities; Mentor junior statisticians on protocol development, analysis plans, and clinical study reports; and Lead planning and analysis of integrated efficacy and safety data across multiple studies.
What are the requirements for this Director, Early Phase Biostatistics role?expand_more
To qualify for the Director, Early Phase Biostatistics 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 role at Daiichi Sankyo US located?expand_more
Director, Early Phase Biostatistics 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.