・国内及びグローバル臨床試験の統計プログラミング業務(SDTM/ADaM/解析資料)及びCDISC関連資料の作成(外部委託時は委託者としての管理及び意思決定を含む)
・各規制当局からの要件を満たすCDISC標準形式の申請電子データの作成及び規制当局からの問い合わせ対応
・統計プログラミング業務の信頼性を担保した業務プロセスの改善提案及び改善活動
*本職種は、部下を持たない専門職を想定
Statistical programming for clinical trials
・Imprementation for in-house or outsourced clinical trial statistical programming work (SDTM/ADaM/TLFs) and creation of CDISC-related materials (including management and decision-making as the client in outsorcing).
・Create electronic study data submitted for the new drug application in CDISC standard format that meets requirements from each regulatory authority and respond to inqueries from regulatory authorities
・Able to propose improvements to business processes that ensure the reliability of statistical programming operations
*Assuming a Professional Line who does not have subordinates
※将来的に会社の定める業務へ変更となる場合があります
This may change in the future as determined by the company.