CLIENT OVERVIEW:

Our Client is a bio pharmaceutical company.

RESPONSIBILITIES:

• Input to statistical strategy and ensure appropriate statistical methodologies applied to study design and data analysis for clinical trials and regulatory submissions
• Provide statistical support in data collection, data analysis, reporting, and submission preparation.
• Be accountable for timely completion and quality of the statistical analysis plan.
• Be responsible for interpreting analysis results and ensuring reporting accuracy.
• Manage outsourcing operations or work with internal statistical programmers within the responsible projects. Ensure timeliness and quality of deliverables by CRO/FSP. Conduct reviews of deliverables to ensure quality.
  • Support Biostatistics interactions with regulatory authorities (eg PMDA, FDA, EMA).
  • Especially for PMDA be responsible for e-data preparation meetings and Form A, including their templates, result accuracy in study report and regulatory submission documents. Support compilation of the CDISC deliverables for the PMDA submissions and ensure its quality per the PMDA requirement as well as biostatistics and programming related interactions, 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).
• Be accountable for the TFL/CDISC package for study report and regulatory submission.
• Support improvement initiatives and related standards for infrastructure / process / scientific consulting
• Conduct ad hoc statistical analyses.

REQUIREMENTS:

Education:

• • PhD or MS in Biostatistics, Statistics, or related fields.

• PhD with 3 years of experience or MS with 6 years of experience in drug development

• Japan native preferred; Strong interpersonal and communication skills (verbal and written in English and Japanese)
• Advanced knowledge and training in applications of statistical methodologies in the context of clinical development
• Ability to collaboratively work and provide leadership in a matrix environment
• Proficient in SAS and/or R
• Familiarity with relevant regulatory guidance documents
• Expertise in
  • CDISC, statistical programming, and/or data standards o
  • Biostatistics and Statistical Programming Operation
• Statistical support in facilitating and optimizing clinical development programs, especially for global studies including Japan (sample size in rare diseases)
• Knowledge of CTD/CDISC submission (SDTM and ADaM) requirements for PMDA
• Basic knowledge of clinical development and processes