Manager Biostatistics
Company: Daiichi Sankyo, Inc.
Location: Basking Ridge
Posted on: January 24, 2023
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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. 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.SummaryPosition leads statistical
support for medium complexity studies including contributing to
development of optimal study design, independently develop and
execute statistical analysis plan and helps in 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 works on
statistical methodology and leads/contributes to internal
statistical workstreams to address various project needs. The
position works closely with contract research organization (CRO)
programmers and statisticians and collaborates with internal
programmers 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.ResponsibilitiesProtocol Development, Case Report Form
(CRF; review), Statistical Analysis Plan (SAP), Statistical
Analysis, Results Interpretation, and clinical study report (CSR):
Leads statistical activities for medium complexity 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. Work closely with internal statistical
programmer.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 AuthoritiesGlobal strategy to Improve Drug Development:
Primarily participates and may occasionally lead moderately complex
biostatistical 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: 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 preferredMaster's
Degree in Statistics/Biostatistics preferredExperience
Qualifications4 or More Years relevant experience in the
pharmaceutical industry with Ph.D preferred4 or More Years with
Masters. preferredDaiichi 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, Inc., Newark , Manager Biostatistics, Executive , Basking Ridge, New Jersey
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