Director Biostatistics
Company: Daiichi Sankyo
Location: Basking Ridge
Posted on: May 12, 2022
Job Description:
Join 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. Join 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. 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 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 Qualifications (from an accredited college or university)
- PhD in statistics or biostatistics requiredExperience
Qualifications
- 7 or More Years of relevant experience in the pharmaceutical
industry required TravelAbility 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. 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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