【1150～1800万円】Senior Statistical Scientist

【求人No NJB2376243】
■Position Purpose:
Provide an overview of the responsibilities of the position by providing a summary of the most important aspects and duties of the position.

The Statistical Scientist provides components of statistical contribution to a clinical development program. The Statistician implements statistical strategies for the clinical trials and regulatory submissions and is accountable for the statistical deliverables. The position will support the Japan clinical/PMS team with statistical expertise ad hoc analyses and interpretation of requests from PMDA. The Statistical Scientist will collaborate with the global CSL team on the design of global studies including Japan and on stand alone studies conducted in Japan only. It is expected that the candidate will be experienced with PMDAs requirements regarding CDISC and to communicate these effectively to the global Biostatistics.

■Main Responsibilities and Accountabilities:
List the roles and responsibilities of the position （please limit the number of responsibilities to the primary ten.）
Support Biostatistics to conduct study data collection data analysis reporting and submission preparation.
Be accountable for timely completion and quality of the statistical analysis plan.
Manage outsourcing operations for assigned projects.
Ensure timeliness and quality of deliverables by CRO and conduct reviews of CRO deliverables to ensure quality.
Support Biostatistics and data management related interactions with authorities （especially PMDA） including submissions to PMDA.
Be responsible for compilation of the CDISC deliverables for the PMDA submissions and ensure its quality per the PMDA requirement.
Be responsible for result accuracy in study report and regulatory submission documents.
Manage preparation for the GCP inspections and lead the discussion at the on site sponsor inspections related to data science areas （biostatistics data collection and data management）
Conduct ad hoc statistical analyses.
Support improvement initiatives and related standards for infrastructure / process / scientific consulting.

■Position Qualifications and Experience Requirements:
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・Education
PhD or MS in Biostatistics Statistics or related fields.

・Experience
At least 5 years of experience in Clinical Development in a Pharmaceutical or Biotechnology setting
Japan native preferred; Strong interpersonal and communication skills （verbal and written in English and Japanese）
Ability to collaboratively work and provide leadership in a matrix environment
Statistical support in facilitating and optimizing clinical development programs especially for global studies including Japan （sample size in rare diseases）
Knowledge of CTD and CDISC submission requirements （SDTM and ADaM） for PMDA is highly preferred
Experience managing CRO preferred
Basic knowledge of clinical development and processes
Experience with statistical programming using the SAS software
Ability for overseas travel （mainly USA） once/twice a year
Desired: Advanced knowledge and training in applications of statistical methodologies