Principal Biostatistics

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Daiichi Sankyo Europe

The position holder will manage, with limited direction, Biostatistics study activities assigned, to support non-R&D functions, and ensure high quality deliverables are on time and within budget.
The position holder will partner with internal and external stakeholders to optimize Statistical methods, processes and standards.
The position holder will act as main statistical contact for the assigned study activities, in particular in cross-functional Study team(s).

Responsible for a clinical study: provide input on the development of study protocol (design, sample size, statistical analysis strategy); Write SAP; Manage statistical analysis outputs with programming team; Ensure the interpretation of statistical results and provide input on reporting (CSR).
Support Medical Affairs and HEOR/HTA strategies: Set-up additional statistical analyses required, including analyses of patient-reported outcomes (PROs) and health economic endpoints; Coordinate the statistical programmers involved in the development and execution of analyses; Provide guidance of the proper interpretation of statistical analysis results; Review or co-author the value dossier and scientific communications.
Contribute to documents submitted to regulatory or pricing authorities.
May participate as subject matter expert in meeting or teleconferences with health authorities.
Responsible for providing direction and execute oversight of vendor delivery.
May lead and/or participate in departemental initiatives to improve the harmonization and efficiency of processes and/or develop and implement innovative solutions.
Maintains current knowledge of industry best practice in statistical methodology.
May act as subject matter expert for statistics representing the department in cross-functional teams.
Responsible for monitoring regulatory guidance and industry best practices to formulate proposals for new functional standards.

Master’s degree or PhD (preferable) in statistics, mathematics or related fields
At least 5 years of experience as statistician supporting drug development and/or post marketing in Clinical research, Pharmaceutical company, CRO or Medical Device setting
Experience in oncology Therapeutic Area and/or in late phase projects is an advantage
Strong knowledge of major statistical methods within industry standards
Proficiency on handling CDISC standards and statistical software such as but not limited to SAS and R
Extended knowledge and understanding of the principles, concepts, methods, and standards of Clinical Research
Demonstrated expertise in study design, conduct and execution
Excellent English language skills
Excellent communication skills, both oral and written, in explaining in simple terms complex concepts
Demonstrated entrepreneurship and leadership and proactive problem solving
Ability and interest to work remotely with worldwide team members across cultures