メディカル・バイオ - 統計解析

Position Summary:
The Clinical Programming Lead is an experienced clinical trial programmer with expertise in industry standard and complex data structures, programming languages, and/or reporting solutions with proven technical capabilities in leading clinical trial activities and/or teams in accordance with departmental processes and procedures.
The position is responsible for providing expertise, planning, creation and oversight of one or more clinical programming trial activities of moderate to high complexity/criticality. Including data models for fit for purpose reporting consumption and/or CDISC submission ready SDTM tabulation packages (aCRF, define.xml, cSDRG, etc). Creates and executes edit check programs, cross and study specific reporting solutions to aid in monitoring of safety, risk, compliance and ensures quality data review. Depending on departmental needs, this position may fulfil the role of a Portfolio Lead.
Responsible for creating efficiencies in the clinical data flow using metadata driven approaches and ensuring the highest level of consistency and quality across trials they support.
Additionally, they provide expertise in relevant technical areas and on process improvement, maintenance and innovation initiatives working proactively to connect with teams, peers and leadership within and cross functions, sharing and implementing lessons-learned and shaping processes and practices.
May perform reporting solutions role creating study specific reports translating clinical study team needs aggregating clinical data sources into custom data and reports to monitor safety, risk and compliance.
The reporting solutions role contributes to the improvement of clinical safety, risk and compliance review and cleaning efficiency by providing innovative and forward-thinking reporting solutions, report library templates, macros and other solutions for use cross studies.

■休日：完全週休二日制, 土, 日, 祝日, 年末年始

Education and Experience Requirements:
• Bachelor’s degree or higher and/or equivalent in computer science, data science/data engineering, mathematics or another relevant scientific field (or equivalent theoretical/technical depth).
• Approximately 6-8+ years of clinical programming/clinical data management experience with increasing responsibility, preferably in the pharmaceutical/clinical trial environment.
• In-depth knowledge of data structures and relevant programming languages for data manipulation and reporting. May include SAS, R, Python, etc. Knowledge of SAS is required.
• Advanced CDISC SDTM knowledge.
• Experience in planning and coordinating one or more team activities as necessary.
• Project management skills and knowledge of team management principles are required.
• Experience working with cross functional stakeholders and teams.
• Demonstrated written and verbal communications skills.
• Vendor management oversight experience.
• Working knowledge of regulatory guidelines (e.g. ICH-GCP) and relevant clinical R&D concepts.

■職種未経験者：不可