- 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 prespecified 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 /
- 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
- Master's Degree in statistics or biostatistics required
- PhD in statistics or biostatistics preferred
- 7 or More Years of relevant experience in the pharmaceutical industry required
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Director of Medical Innovation - Basking Ridge, NJ, United States - Daiichi Sankyo, Inc.
Description
Join a Legacy of Innovation 110 Years and CountingDaiichi 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 16,000 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 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
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.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)
Ability 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.
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