Principal Biostatistician

Company Overview
◆グローバルランキング5位以内
◆ヨーロッパヘッドクオーター
◆癌、呼吸器、循環器、眼科領域を始め幅広い領域にパイプラインを持つ
◆癌領域に最先端の技術

Job Description
Principal Biostatistician

Role profile
The Principal Biostatistician is responsible for all statistical work, scientific and operational, for one or more assigned trials and/or post-marketing surveillances (PMS) in Japan in collaboration with the clinical trial team, and also takes on project level tasks as a Japan representative of biostatistics in the project team. May support project level deliverables for a development project under limited supervision.
Leads implementation of modern and innovative clinical trial/experimental designs, statistical models, analyses and data exploration at the study level.

Main Activities
・ Responsible for all statistical tasks on assigned trials, and perform these tasks independently seeking peer input/review as required. Responsible for protocol development in alignment with the development plan, developing statistical analysis plans, reporting activities. Contribute to planning and execution of exploratory analyses, and/or PK, PK/PD analyses, exploratory biomarker and diagnostic analyses, and statistical consultation. Initiate, drive and implement novel methods and innovative trial designs in alignment with the Lead Statistician.
・ Explain statistical methodology and interpret analysis results. Provide statistical expertise to support submission activities and documents, meetings with and responses to Health Authorities and other drug development activities, as required.
・ Contribute to interactions with external review boards/ethics committees, external consultants and other external parties with oversight as appropriate.
・ Represent the company in statistical discussions at external congresses,conferences, scientific meetings.
・ Represent the Biostatistics & Pharmacometrics Line Function on cross-functional teams for the assigned trials. Responsible for functional alignment and ensuring line function awareness of status and issues related to the assigned trials.
・ Collaborate with other line functions. Explain statistical concepts in manner easily understood by non-statisticians and provide adequate statistical justifications for actions/decisions/statements as required.
・ Establish and maintain sound working relationships and effective communication within the Clinical Trial Team and Biostatistics & Pharmacometrics team.
・ Oversee all Biostatistics resources and deliverables for assigned trials. Ensure timeliness and adequate quality of all Biostatistics deliverables for the assigned trials and/or non-clinical related activities.
・ Responsible for all statistical tasks on the assigned PMS, including development of protocol and statistical analysis plan based on standardized templates and reporting activities in collaboration with preferred vendors.

Requirements
Qualifications
・ Education: MS (in Statistics or equivalent) with 4+ years relevant work experience or PhD (in Statistics or equivalent) with relevant work experience (including internship)
・ Languages: Fluent English (oral and written)
・ Good communication and presentation skills.

Experience/Professional
Requirement:
・ Influences decisions that directly impact the assigned clinical trial and team ability to deliver objectives.
・ Proven knowledge and expertise in statistics and its application to clinical trials. Depending on the assignment, may require proven expertise in pharmacokinetics, exposure-response modelling, exploratory biomarker, diagnostic analyses, applied
・ Bayesian statistics, or data exploration skills.
・ Proficiency in use of statistical software packages (e.g. SAS, R). Knowledge of drug development and Health Authority guidelines. Able to work on and collaborate seamlessly with a multidisciplinary team to achieve team objectives.
・ Experience in Franchise/Therapeutic Area and/or regulatory activities desirable.

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