Pharma / Biotech / Healthcare / Medical
Programmer I/II (SAS Programmers)
-Deliver best value and high quality service.
-Check own work in an ongoing way to ensure first-time quality.
-Maintain all supporting documentation for studies in accordance with WSOPs/Guidelines to ensure traceability and regulatory compliance.
-Ensure compliance with WSOPs/Guidelines, ICH-GCP and any other applicable local and international regulations and participate in internal/external audits and regulatory inspections as required.
-Develop wider knowledge of areas of Clinical Data Management Systems (CDMS), Electronic Data Capture (EDC), Clinical Trial Management System (CTMS), Safety Reporting, SAS and other programming language usage and processes within the GRO, biostatistics, and medical arenas.
Clinical Systems and Support Programmer
-Execute ongoing maintenance tasks, performance evaluations and tuning of eClinical applications/systems.
-Set up / configure automatic reports for studies within the eClinical applications/systems.
-Execute automatic import and export of data.
-Create, implement and execute procedures to build and maintain database set-up for paper based and/or web based (EDC) clinical data management systems (CDMS) in standard format or CDISC compliant format as required, including the annotation of CRF¿s where applicable.
-Create, implement and maintain consistency checks in standard or CDISC format for database builds in CDMS and EDC, following and understanding internal and external regulatory requirements.
-Create, implement and execute import and export programs, in either standard format, client specific format or CDISC compliant format depending on nature of request.
-Perform small ad-hoc programming tasks.
-Use efficient programming techniques to produce low-medium complexity derived datasets, tables, figures and data listings
-Experience in at least one programming environment (e.g., SAS, CDMS, EDC, SQL, VB, Java).
-Knowledge of the programming and reporting process within the GTS Department.
-Knowledge of WSOPs/Guidelines/System Life Cycle methodologies, ICH-GCP and any other applicable local and international regulations such as 21 CFR Part 11 and proven practical application.
-Demonstrate ability to learn new systems and function in an evolving technical environment.
-Attention to detail.
-Ability to work together with a team (including international teams as required) as well as independently.
-Work effectively in a quality-focused environment.
-First degree (undergraduate or equivalent) in a relevant discipline is preferred or equivalent work experience.
-Excellent written and oral communication skills.
Minimum Relevant Work Experience of 2 - 5 years in Clinical SAS is recommended.
Note: Candidate with Relevant SAS Programming experience in Clincial domain can send the CV to Kirloskar.email@example.com