Biostatistics Manager

* Design and execute biostatistic aspect of clinical studies in Japan
* Lead team of statisticians across JAPAC
Client Details
* Well known global biopharmaceutical company with rich development pipeline and diverse product portfolio in Oncology, CNS, Cardio/Metabolic and Neuroscience areas.
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.
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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.
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Participate in the design of case report forms and reviews data validation specifications and other data management documentation associated with clinical study database development.
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Develop, review and approve statistical analysis plans.
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Research, develop and implement statistical methods appropriate to clinical study design and objectives and consistent with current regulatory standards and requirements.
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Design the layout and content of tables, figures, and listings in accordance with statistical analysis plans.
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Participate in regulatory submission planning, including data submission strategies and the creation of integrated summaries.
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Represent company in discussions and meetings with regulatory agencies.
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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.