Senior Biostatistician

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Job description

Position Title: Senior Biostatistician

Join a Legacy of Innovation 125 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 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 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 statistical support for low to medium complexity studies including contributing to development of optimal study design, follow and execute statistical analysis plan and helps in interpretation of results with supervision. This position contributes to specific aspects of drug development plans with supervision and contributes to documents submitted to Health Authorities globally with 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. This position works under supervision to solve complex study problems.

Responsibilities:

• Protocol Development, Case Report Form (CRF; review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Executes statistical activities for low to medium complexity studies including study design, protocol development, CRF review, SAP development, analysis files development, data surveillance review, 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; works closely with statistical programmers in statistical analyses execution, quality control, and data derivation; collaborates closely with data manager to ensure high quality data. Work closely with internal statistical programmer.

• Global strategy to Improve Drug Development: Primarily participates and may occasionally lead moderately complex biostatistical initiatives, with supervision, to improve the harmonization and efficiency of drug development which leads to cost savings and shortened timelines for the company.

• CRO / Vendor Oversight: Review CRO/vendor proposal and budget. Set 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 Authorities

Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

Education:

• Master's Degree: minimum 3 years' experience with a master's degree in statistics or biostatistics required

• PhD: 0- 2 years relevant experience in the pharmaceutical industry with Ph.D. in statistics or biostatistics or equivalent field.

• Ph.D. is strongly preferred

Experience:

• Strong knowledge of statistical methodologies.

• Some understanding of current drug development trends and regulatory environments.

• Sufficient programming skills in SAS and/or R and working knowledge of software such as nQuery, East, etc.

• Strong analytical and problem-solving skills.

• Some knowledge of pharmacology, clinical research, and medical terminology and use it for study design and results interpretation.

• Excellent oral and written communication skills in English.

• Ability to identify and investigate issues and causes and formulate potential solutions with supervision.

• Ability to prioritize multiple tasks, develop instructions and manage vendors and collaborate with internal programming colleagues in completing the deliverables with high quality according to timelines, and provide recommendations to improve process.

• Compliant with internal and external compliance practice to ensure integrity of work and suggest innovative approaches to improve compliances and processes.

• Some knowledge of clinical trial methodologies.

Travel:

• Ability to travel up to 10%

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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