Director, Biostatistics
Company: Daiichi Sankyo
Location: Basking Ridge
Posted on: February 20, 2021
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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.
Keywords: Daiichi Sankyo, Newark , Director, Biostatistics, Executive , Basking Ridge, New Jersey
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