Director Statistical Programming
Company: Daiichi Sankyo, Inc.
Location: Atlanta
Posted on: April 26, 2024
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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 technologyWith 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 peopleUnder 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 disordersSummaryProvide strategic leadership
for all statistical programming activity related to study, project
and submissionManage CRO to ensure high quality compound and
multi-compound level deliverablesLead the development of global
harmonization of programming processes supporting global
submissionResponsibilities - Statistical Programming Management:
Coordinates outsourced statistical programming of analysis data
sets and tables, listings, and figures (TLFs) needed for clinical
study reports and regulatory submissions, as well as in-house
validation of this workPossesses in-depth knowledge of regulatory
authority's requirementsTypically has administrative responsibility
for recruiting, retaining, developing, and managing employeesGuide
career growth and provide development opportunity for statistical
programmersManages contract statistical programming staff to ensure
proper resource allocation for achieving successful project
deliverablesProvides oversight of all statistical programming
activities performed by contractors in different oncology trials as
well as submission-related activities, e.g., integrated summary of
safety (ISS) and integrated summary of efficacy (ISE)- Direct
Project Support: Providing direct support to key studies in order
to ensure sufficient planning of statistical deliverables from
vendors as well as work by in-house statistical programmers- CRO /
Vendor Oversight: Manages higher-level negotiations and provides
oversight of budget, resources, and timelines for contract research
organizations (CROs) for multiple projects and ensures timely
delivery of high quality deliverables at reasonable
costIdentify/develop tools for efficient vendor management- Global
Health Authority Interaction / Negotiation: Reviews documents and
responses submitted to health authorities globally with respect to
data standards, compliance, etcMay represents the function at
health authority meetingsReviews and provides input to TLF shells
for submission documents (e.g., ISE and ISS)Develops the process
for ensuring that analysis data sets and outputs are compliant with
regulatory requirements, including CDISC ADaM data set
specifications, reviewer's guides, etc- Global Biostatistics Data
Management (BDM) Strategy to Improve Drug Development: Leads
implementation of vision and strategy, and identifies technology
needs for the function to improve the harmonization and efficiency
which leads to cost savings and accelerated worldwide product
submissions and approvalsAuthors or initiates writing of global
standard operating procedures for statistical programming practice,
especially with respect to oversight of vendor performanceOversees
compliance with standard procedures and processesLeads the
development and refinement of analysis data standards for AML as
well as solid tumor studies- Leadership of Strategic Initiative and
Cross-Functional Collaboration: Provide leadership for strategic
and process improvement initiatives within Biostatistics Data
ManagementWorks with colleagues at DST and DSE to identify
opportunities for global harmonization and process
improvement.Ensure close collaboration with other functional areas
such as biostatistics, data management, clinical operations,
pharmacovigilance, regulatory affairs, etcQualifications:
Successful candidates will be able to meet the qualifications below
with or without a reasonable accommodationEducation Qualifications
(from an accredited college or university) - Bachelor's Degree an
accredited institution in a science or in a technical field
preferred - Master's Degree preferred Experience Qualifications -
10 or More Years experience (Bachelor 12 or More Years) in
pharmaceutical industry preferred - Thorough understanding and
proficiency of CDISCpreferred - Advanced knowledge of CDISC
requirements for SDTM and ADaMpreferred - Worked and played major
role in electronic NDA and/or BLA submission via eCTD preferred -
Working knowledge in statistics as measured by ability to interpret
SAPs/shells to generate ADaM and TLFspreferred - Strong project
management experience and ability to manage and execute multiple
projects and deadlinespreferred Daiichi Sankyo, Incis an equal
opportunity/affirmative action employerQualified 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., East Point , Director Statistical Programming, Executive , Atlanta, Georgia
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