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.

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