仕事内容Provide strong statistical leadership in the process of drug development.
The statistical analyst provides strong leadership in the process of drug development, by preparing CDISC complied databases, statistical summary table/figures in accordance with a schedule. During the development of protocol designs, data analysis plans, and regulatory interactions, it is expected to collaborate with relevant study team members and provide assists from statistical analyst point of view.
【主な職責/Primary responsibilities】
●Statistical Analysis Results Delivery
・Operate in collaboration with global counterparts to prepare CRT packages appropriately meet with regulatory requirements.
・ Understand selecting statistical methods for data analysis, then prepare programing codes for delivering analysis datasets and outputs accordingly.
・Collaborate with data management in the planning and implementation of data quality assurance plans.
・Maintain currency with respect to standards, dictionaries, computational tools for statistical methodology, and regulatory requirements.
・Obtain project management skillset to coordinate delivering database and/or statistical outputs.
・Participate in peer-review work products from other statistical colleagues.
・Seek for any innovations towards more efficient working model realized.
●Use Communication Skillsets
・Collaborate with team members and/or global counterparts to deliver statistical results on time.
・Coordinate workers dedicated to preparing statistical datasets and outputs.
・Present any topics related to own responsibilities, such as new tools, methodologies, regulatory requirements, etc.
・Respond to regulatory queries and to interact with regulators.
・Reach out external parties to make environmental shaping happen.
●Therapeutic Area Knowledge
・Understand disease states and related medical assessments for preparing appropriate definitions and/or specifications that fulfills statistical analysis objectives.
●Regulatory Compliance
・Perform work in full compliance with assigned curriculum(s) and will be responsible for following applicable Corporate, Medical, local, and departmental policies, procedures, processes, and training.
●Statistical leadership and Teamwork
・Introduce and apply innovative methodology and tools to solve critical problems.
・Merge scientific thinking and business knowledge to identify issues, evaluate options and implement solutions.
・Lead projects independently and work effectively across functions. Apply technical expertise to influence business decisions.
経験・資格【必須経験/スキル・資格】
・どちらかを満たす方
-M.S. in statistics, biostatistics, or computer science, but not limited to. Any relevant certifications would be acceptable.
or
-Rich experiences in healthcare field as a computational statistician with science background such as biology or epidemiology.
・Statistical/methodological knowledge and computational skill in clinical development, epidemiology, or related field.
・Regulatory knowledge of clinical trial methodology and statistics.
・Ability to build relationships with individuals and teams.
・Good communication and presentation skills in both English and Japanese
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東証プライム上場 老舗光学機器メーカー FPD装置事業部 構想設計エンジニア
東証プライム上場 日系大手コンサルティングファーム コンサルティング本部 シニアコンサルタント
大手総合人材サービス会社 テクノロジー本部 デジタルテクノロジー統括部 データサイエンティスト
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