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2024.5.24 [Fri.]

Akihabara UDX 2F AKIBA_SQUARE

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Updated 2024-03-19
Activated 2024-03-19

Biostatistics Manager

Recruiter
Manager Level

This posting is managed by:	Michael Page International Japan K.K./マイケル・ペイジ・インターナショナル・ジャパン株式会社
Company Name	Company is not publicly visible
Job Type	Medical/Pharmaceutical/Bio/Fabric/Food - Clinical R & D
Industry	Pharmaceuticals
Location	Asia Japan Tokyo
Job Description	* Design and execute biostatistic aspect of clinical studies in Japan * Lead team of statisticians across JAPAC Description * Responsible for directing the biostatistics activities in collaboration with HQ, from trial design, execution, analysis, and data interpretation. * Serve as regional subject matter expert for specific programs and TAs and provides leadership to support all clinical studies, regulatory submissions, and publications for the program or therapeutic area. * Participate in development of clinical study protocols, including experimental design, specification of analysis endpoints, determination of sample size, and specification of methods of statistical analysis. * Participate in the design of case report forms and reviews data validation specifications and other data management documentation associated with clinical study database development. * Develop, review and approve statistical analysis plans. * Research, develop and implement statistical methods appropriate to clinical study design and objectives and consistent with current regulatory standards and requirements. * Design the layout and content of tables, figures, and listings in accordance with statistical analysis plans. * Participate in regulatory submission planning, including data submission strategies and the creation of integrated summaries. * Represent company in discussions and meetings with regulatory agencies. * Plays a key role in the development of biostatistics processes and procedures, including the writing and review of department standard operating procedures. Profile * Ideally MS or PhD in Statistics, or equivalent amount of experience the pharmaceutical industry including design, analysis, and reporting of clinical studies. * Significant experience with regulatory submissions and interactions with regulatory agencies. * Extensive experience with the design, analysis, and reporting of Phase 1 through Phase 4 clinical studies and observational studies, and the development of drug development strategies in the pharmaceutical industry setting. * Demonstrated leadership skills as biostatistics lead on multiple clinical programs. * Hands-on experience with developing detailed statistical analysis plans and designing tables, figures, and listings for clinical study reports. * Knowledge of current topics and issues related to the design and analysis of clinical studies, including adaptive designs, multiplicity, handling of missing data, and sensitivity analyses. * Strong oral and written communication, as well as problem-solving skills, are essential; ability to proactively identify issues and determine appropriate solutions to complex problems. * Excellent working knowledge of the SAS software package; ability to communicate effectively with SAS programmers, review SAS output, and write SAS code as needed. * Strong working knowledge of current regulatory requirements related to the submission of clinical study data and statistical programs. * Experience in the development of integrated summaries of safety and efficacy. Demonstrated expertise in implementation of CDISC standards applicable to regulatory submissions. * Ability to handle multiple projects at one time and direct resources appropriately to address frequent changes in priorities. * Fluent English and Japanese skills Job Offer * Opportunity to lead biostatistics projects at a country level within a major global biopharmaceutical company Page Group Japan is acting as an Employment Agency in relation to this vacancy.
Company Info	* Well known global biopharmaceutical company with rich development pipeline and diverse product portfolio in Oncology, CNS, Cardio/Metabolic and Neuroscience areas.
Working Hours	Monday - Friday 09:00 - 17:00
English Level	Business Conversation Level (TOEIC 735-860)
Japanese Level	Fluent(JLPT Level 1 or N1)
Salary	JPY - Japanese Yen JPY 12000K - JPY 15000K

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