Associate Director, Biostatistics (Late Stage Oncology)

Daiichi Sankyo; Basking Ridge (NJ); On-site; USD 175,000 - 263,000; Full time

Job summary

Daiichi Sankyo is seeking an Associate Director, Biostatistics (Late Stage Oncology) to lead complex studies, contribute to development plans, and guide CRO statisticians. The role interfaces with study teams, data managers, and regulators to deliver rigorous analyses and timely results in global drug development.

Senior biostatistist leadership is required, with extensive experience in late-stage oncology trials and CRO coordination to ensure quality analysis files and regulatory-ready outputs.

Qualifications

• Must have strong statistical expertise in late-stage clinical trials.
• Experience leading complex studies and interacting with study teams.
• Ability to guide CROs and programmers in analysis deliverables.

Responsibilities

• Lead statistical activities for complex late-stage oncology studies.
• Collaborate with data managers to ensure high quality data.
• Provide input to development plans and regulatory submissions.
• Oversee CRF review, SAP development, and CSR input.
• Interact with Health Authorities and global teams on analyses.
• Mentor statisticians and programmers in CROs.

Skills

Biostatistics

Study design

CRO oversight

Education

Master's Degree in statistics or biostatistics

PhD in statistics or biostatistics preferred

Job description

Associate Director, Biostatistics (Late Stage Oncology)

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 more than 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.

Job Summary

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

Job Description

Responsibilities

• Protocol Development, Case Report Form (CRF; review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR):
• 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

Education Qualifications

• Master's Degree in statistics or biostatistics required
• PhD in statistics or biostatistics preferred

Experience Qualifications

• 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

Travel Requirements

Ability 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.

Salary Range:

USD$175,440.00 - USD$263,160.00

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