The job holder is accountable for the quality of work performed.
Develops, modifies and maintains programs to support Project Management, Data Management, Biostatistics and Medical departments. This includes lab reconciliation programs, metrics reports, data review listings, and other reports as needed. Manages multiple large data sets (SAS), including data mapping from base eCRF elements to CDISC/SDTM.
Key Responsibilities:
1. Support and ensure the preparation, transfer and integration of clinical data from internal and external sources into the study database.
2. Provide data in various formats and applications to data management customers.
3. Full study programming and validation responsibility - Develop, program, test and maintain computer edit/validation checks.
4. Provide technical expertise and programming support for Liquid Minds IT projects and data management staff.
5. Communicate project status and key project issues to Data Project Manager (DPM).
6. Provides metric reports for monitoring the progress of projects and processes for reporting to management and project teams.
Working Relationships:
Direct reporting line to Manager, Data Systems, with functional reporting line to Manager, Data Management or others as appropriate.
Collaborate with DPM, Lead DMs and Data Systems Team.
Education Requirements and Qualifications:
Bachelor’s degree (or equivalent) – preferred with experience in the pharmaceutical/CRO industry and 1 year experience as a SAS programmer. SQL/SAS and SAS ODS experience preferred.
Good understanding of the drug development process.
Very good understanding of data handling processes and preferable clinical data programming
Experience in SAS programming and/or using data management technologies (e.g. clinical data management systems, electronic data capture, data review tools, data warehousing)
Good understanding of regulations, standards and guidelines (e.g. ICH, GxP, CDISC, European Clinical Trials Directive, Privacy rules [HIPPA])
Good oral, written and interpersonal communication skills.
High proficiency with Office Systems, including Word and Excel.
Good problem solving, analytical, and time management skills.
Customer focus, flexibility.
Understanding of relational database theory and practice, including writing stored procedures, functions, and views.
Experience using Data Flow Diagrams, Entity Relationship Diagrams and data modeling tools.
An ability to work independently, attention to detail, a willingness to take initiative, an ability to adapt to change, and strong organizational skills are required.
The requirements of this position may be waived by Liquid Minds IT Senior Manger in whose opinion the stated requirement are offset by other substantial and (in)direct experience.
NO PHONE CALLS PLEASE. PRINCIPALS ONLY, NO AGENCIES.
For confidential consideration, please send CV to careers@winonco.in NO PHONE CALLS PLEASE.