Director, Biostatistics

Company: Daiichi Sankyo
Location: Basking Ridge
Posted on: February 20, 2021

Job Description:

Director, Biostatistics in Basking Ridge, NJ at DSI Job DescriptionJoin a Legacy of Innovation 110 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 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 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.

Job Summary:

Position leads very complex studies or entire drug project in study design, data analysis and interpretation of results independently with minimal supervision. This position provides input to entire drug development plans with minimal supervision and authors regulatory responses and other documents with minimal supervision. This position 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:

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. Act as statistical
expert in the assigned projects. Guides the project team in using the most efficient or innovative study design
by considering the regulatory agencies' requirements for the country and Regions the compound will be
submitted, and helps to maximize the success of the drug product.

Serves as project statistician and ensures the study designs are scientifically sound, the efficacy and safety
information meets regulatory requirements of the countries and Regions the drugs will be submitted. 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; Review the relevant sections of the electronic common technical document (eCTD).

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, proposed studies have appropriate
designs, efficacy and safety information to be collected meet regulatory agencies' requirements for countries
and regions the drug is to be submitted.

Research statistical methodologies and addresses specific statistical issues in the design of clinical studies from
preclinical through Phase 3 and 4.

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.

Global Health Authority Interaction / Negotiation: Authors documents and responses submitted to Health
Authorities globally with some guidance from supervisor. Represents statistics function to Health Authorities
meetings as needed.

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/Experience:

PhD in statistics or biostatistics required

7 or more years of relevant experience in the pharmaceutical industry 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. Candidates with Disabilities Who Require Assistance Daiichi Sankyo, Inc. provides reasonable accommodation in job application procedures for qualified individuals with disabilities and disabled veterans. If you have a disability that inhibits your ability to apply for a position through our online application process or you otherwise need accommodation in connection with the recruiting process due to a disability, you may use the alternative methods described below to contact us about your interest in Daiichi Sankyo, Inc. and/or to request an accommodation. Daiichi Sankyo, Inc.
211 Mt. Airy Road Basking Ridge, NJ 07920-2311
Attn: Staffing Dept. By Phone: Phone: 908-992-6400 Equal Opportunity Employment 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.

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