Clinical Programmer, Data Science Lead
Utilize Clinical Programming Expertise to Expedite Clinical Trials
Contribute to Approval of Innovative Medicines at Leading Pharma Company
- Industry leading European pharmaceutical company, with expertise in oncology, immunology, infectious disease, cardiovascular disease areas
- Extract clinical data from the clinical data management system and produce standard and custom reports, primarily in SAS.
- Program reports and listings as requested by project team members for ongoing studies.
- Develop transfer specifications with vendors for external data sources.
- Perform consistency checks on data transferred between company and external parties to ensure completeness and accuracy of data contained transfers.
- Perform programming to convert raw, clinical trial data to Study Data Tabulation Model (SDTM) format.
- Perform Quality Control (QC) on programming work performed by fellow Database Programmers.
- Create and validate global macros or systems that streamline repetitive operations to increase programming efficiency.
- Bachelor's degree
- Fluent Japanese and English
- Minimum of 5 years of clinical SAS programming experience in the pharmaceutical industry.
- Working knowledge of CDISC SDTM mapping/specs/conversion/domains/datasets/eCRF/eCRT Package/define.xml development and SDTM data transfer operations on clinical studies.
- Understanding of regulatory requirements relevant to submissions.
- Knowledge of clinical trial study design and electronic data submission requirements.
- Communication and interpersonal skills and the ability to work effectively as part of a team.
- Work in an international environment, clear career development opportunities, contribute to global clinical studies