Sr. Manager Biostatistics - 製薬会社

お問合せ Hidetoshi Sato
JOB ID JO-2208-473730

MANDATORY

  • Applicants must have permission to work in Japan
  • Applicants must be able to speak fluent ~ native level Japanese (Equivalent to JLPT N1)

☑外資系企業 ☑リモートワーク可

[ポジション]
Sr. Manager Biostatistics

[事業内容・会社の特徴]
Global Pharmaceutical Company

[仕事内容]
Position Summary
The Senior Manager Biostatistics is responsible for statistical activities in support of clinical trials and NDA submission, including but not limited to the following: contributing to trial designs, authoring statistical sections of protocols, preparing statistical analysis plans, and reviewing and interpreting the analysis of clinical trial data.

Principal Responsibilities:

  • Collaborates with Japan and Global-Biostatistics, Clinical Development, Clinical Pharmacology, Regulatory and Clinical Operations expertise areas to design clinical trials.
  • Writes the statistical sections of clinical trial protocols, while consulting with internal and external experts
  • Contributes to or prepares statistical analysis plans and Data Presentation Plans
  • Collaborates with Japan and Global-Biostatistics, Data Management, Clinical Development, Clinical Pharmacology and Clinical Operations on design of eCRFs
  • Provides statistical guidance on conduct of ongoing trials
  • Collaborates with Statistical Programmers on summary
  • Contributes to clinical study reports and other regulatory documents e.g. DSURs, Briefing Documents, etc.
  • Contributes to scientific articles, summarizing data collected in trials.
  • Contributes to or prepares marketing applications (NDA) to regulatory agency.
  • Participates in other activities and meetings to support Biostatistics and the Global Program Team as needed.
  • Consults with Research & Preclinical colleagues on statistical questions in their work.
  • Manages CRO statistical and programming support.

[応募資格]

  • PhD in Biostatistics, Statistics, or equivalent with at least 4 years pharmaceutical biostatistics experience or MS with at least 6 years of relevant experience.
  • Excellent written and oral communication skills
  • Excellent presentation and interpersonal skills
  • Experience programming in SAS
  • Experience with simulations (design, implementation and interpretation)
  • Understanding of ICH GCP as well as general knowledge of industry practices and standards
  • Familiarity with R programming language and other statistical software, including EAST
  • Experience with CDISC, including SDTM, ADaM, CDASH

[給与]
1100万円〜1400万円

[休日休暇]
完全週休2日(土曜日、日曜日)、有給休暇、年末年始休暇、慶弔休暇 等

[選考プロセス]
書類選考、面接数回を予定

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Reference: JO-2208-473730
#LI-REMOTE
Seniority Level:Mid Senior Level
Job Function: Analyst, Management