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Job Overview
Performs independent programming activities using Medidata Rave on multiple projects concurrently with minimal support from senior programmers. Development and implementation of solutions to global technical service issues related to EDC tools such as Medidata RAVE, Oracle Inform, and data/report programming via Visual Analytics tools like Spotfire or Tableau. Creates CRF annotations and programming specifications for dataset creation using transfer guidelines, CDISC, and client standards. Develops and maintains SAS programs for dataset creation, imports external data, transforms to SAS datasets or Excel files for review and reconciliation. Maintains study databases, performs SAS programming as assigned, prioritises workload to meet specified completion dates.
Summary of Responsibilities
- Performs independent programming activities on multiple projects concurrently with minimal support from senior programmers. Develops and implements solutions to global technical service issues regarding EDC tools and other programming languages/tools.
- Reads and understands requirement documents/specifications, database design, SAS programming, report design, and conducts quality control processes including database review to meet client requirements.
- Programs ad‑hoc/scheduled reports using SAS, Python, Cognos, Business Objects XI/R, and other tools for data cleaning and reporting.
- Develops/validates programming specifications for mapping of SDTM datasets.
- Produces Define XML/pdfs, annotated eCRFs, and Reviewers Guide for submission deliverables.
- Develops visual analytics dashboards using tools like Spotfire/ Tableau.
- Performs post‑production changes, publish checks, complex structure dynamics, Rave Safety Gateway, RTSM mapping, and enhancements to programs such as SAS edit checks, listings, protocol deviations, etc.
- Completes assigned work utilizing EDC tools or SAS or other proprietary software according to company SOPs, work instructions, project guidelines, and Good Clinical Practice.
- Trains and mentors the team on EDC tools or SAS as required, enabling them to perform independently on day‑to‑day activities.
- Serves as lead statistical programmer providing support for development and maintenance of SAS datasets per CDISC/client standards.
- Plans, executes, and oversees all programming activities on a study, including resource estimation, meeting timelines, maximizing quality, interaction with other departments, and the client.
- Develops/validates programming specifications for generation of SAS datasets per client/CDISC standards.
- Programs edit checks/quality checks on source data and communicates data issues to data management.
- Performs quality checks and ensures deliverables meet quality standards and compliance regulations.
- Continuously learns and improves communication, technical, and problem‑solving skills.
- Interacts with project team members in related disciplines and provides solutions to operational issues.
- Works independently on multiple sponsors and accepts new challenges in clinical programming applications.
- Reconciles database build, project files, reports, listings, and other programming documentation for accuracy and completeness.
- Works in a timely manner in accordance with all activities specified in the agreed study budget, under supervision of senior programmers.
- Performs other duties as assigned by Manager.
Qualifications (Minimum Required)
- University/college degree in life sciences, health sciences, information technology, or related subjects preferred.
- Experience and/or education equivalent to a bachelor’s degree is acceptable in lieu of a bachelor’s degree.
Experience (Minimum Required)
- 4–7 years of relevant work experience including data management and database support: EDC systems programming, SAS programming, Spotfire, or Tableau development.
- Good problem‑solving skills and proactive approach.
- Good oral and written communication skills.
- Knowledge of clinical trial processes, data management, biometrics, and systems applications to support operations preferred.
- Ability to work in a team environment.
- Ability to work effectively under minimal supervision.
- Ability to prioritize work and self‑motivation.
- Good time‑management skills and ability to work to tight deadlines while maintaining high quality.
- Cooperative and team‑oriented approach.
Preferred Qualifications
- University/college degree in life sciences, health sciences, information technology, or related subjects preferred.
Physical Demands/Work Environment
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Seniority level: Mid‑Senior level
Employment type: Full‑time
Job function: Engineering and Information Technology