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Clinical Development Biostatistician

Clinical Development Biostatistician (BBBH2300339) Tokyo, Japan


Job Title: Clinical Development Biostatistician
Job Type: Permanent Full-Time
Worksite: Tokyo, Japan (onsite)

The permanent full-time Clinical Development Biostatistician will be responsible for implementing statistical strategies for clinical trials and regulatory submissions, and to provide the statistical contribution to a clinical development program, including e-data and CDISC for submission to Pharmaceuticals and Medical Devices Agency (PMDA).

CANDIDATES MUST HAVE:

  • MS in Biostatistics, Statistics, or related fields
  • Minimum of three (3) years of experience in drug development
  • Experience with submissions to Pharmaceuticals and Medical Devices Agency (PMDA) and maintaining strong relationships during negotiations.
  • Good working knowledge of SAS and/or R
  • Experience in CDISC and Data Management is preferred
  • Advanced knowledge and training in applications of statistical methodologies
  • Strong interpersonal and communication skills (native Japanese, verbal and written in English)

DUTIES & RESPONSIBILITIES:
The responsibilities of this job include, but are not limited to:

  • Support development of components (CSR, CTD, CDISC, e-Data, DSUR) for submission to PMDA and interact with global and local team
  • Provide global Biostatistics support in study data collection, data analysis, reporting, and submission preparation in close collaboration with global DM and Statistical Programming
  • Conduct ad hoc statistical analysis, including surveys utilizing Medical Information Databases (per PMDA requirement), and support Biostatistics interactions with PMDA as part of the response/inspection team.
  • Perform quality control of the key e-data and CDISC deliverables
  • Perform statistical research or assist in evaluating statistical methodology related to drug development
  • Implement sound statistical methods related to drug development
  • Be responsible for result accuracy in study report and regulatory submission documents including archiving documents


** Only candidates selected to be moved forward in the recruitment process will be contacted by SRG's Recruitment Team to schedule a conversation.


SRG is an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.

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