Director, Biostatistics - Oncology

Daiichi Sankyo; New Jersey; On-site; USD 100,000 - 160,000; Full time

Job summary

An established industry player is seeking a skilled statistician to lead complex drug development projects. This role involves overseeing statistical analysis, guiding project teams, and ensuring compliance with regulatory requirements. The ideal candidate will have a strong background in statistics and extensive experience in the pharmaceutical sector. Join a dynamic team dedicated to innovative therapies that improve global health standards. This is an exciting opportunity to influence the future of drug development while working collaboratively with global teams and health authorities.

Qualifications

• 10+ years of experience in the pharmaceutical industry required.
• Master's degree in statistics or biostatistics is necessary.

Responsibilities

• Lead statistical activities for complex studies and projects.
• Provide input to drug development plans and ensure regulatory compliance.
• Interact with global project teams and oversee CROs.

Skills

Statistical Analysis

Protocol Development

Data Interpretation

Drug Development Strategy

CRO Oversight

Global Health Authority Interaction

Education

Master's Degree in Statistics

PhD in Statistics

Job description

Join a Legacy of Innovation 125 Years and Counting!

Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.

Summary:

This position leads very complex studies or entire drug projects in study design, data analysis, and interpretation of results independently with minimal supervision. It provides input to entire drug development plans and authors regulatory responses and other documents. The role interacts with global project teams and global Health Authorities, as well as contract research organization (CRO) programmers and statisticians. Additionally, this position works under minimal supervision to solve complex project problems.

Responsibilities:

1. Protocol Development, Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and Clinical Study Report (CSR): Leads statistical activities for very complex studies or an entire project. Acts as statistical expert in the assigned projects. Guides the project team in using the most efficient or innovative study design, considering the regulatory agencies’ requirements, and helps to maximize the success of the drug product. Serves as project statistician and ensures the study designs are scientifically sound, and the efficacy and safety information meets regulatory requirements. Ensures consistency in data collection, derived data definition, analysis file structure, statistical analysis, and result interpretation throughout the drug project; Leads the planning and analysis of integrated efficacy and safety data; Reviews the relevant sections of the electronic common technical document (eCTD).
2. Drug Development Strategy: Provides input to the entire development plan to ensure the overall strategy can deliver the pre-specified product profile, is logical, scientifically sound, and proposed studies have appropriate designs. Researches statistical methodologies and addresses specific statistical issues in the design of clinical studies from preclinical through Phase 3 and 4.
3. CRO / Vendor Oversight: Participates in drafting request for proposal for CRO selection. Reviews and negotiates baseline budget and timelines; Guides CRO biostatistician and statistical programmers on assigned projects to ensure consistency in derived data definition, analysis files structure, analysis methodologies, and accuracy of analysis results. Ensures timely delivery of high-quality deliverables.
4. Global Health Authority Interaction / Negotiation: Authors documents and responses submitted to Health Authorities globally with some guidance from supervisor. Represents the statistics function in Health Authorities meetings as needed.
5. Global BDO Strategy to Improve Drug Development: Leads global BDO initiatives to improve the harmonization and efficiency of drug development which leads to cost savings with minimal supervision.

Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

Education Qualifications (from an accredited college or university)

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

Experience Qualifications:

• 10+ Years of relevant experience in the pharmaceutical industry with a master's degree required
• 7+ Years of relevant experience in the pharmaceutical industry with a PhD preferred

Travel: Ability to travel up to 20% International travel required

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.