|Job Type: Full Time| | Job Reference: CHANITSAS003 |
Summary
The Duties of Job
Generate analysis datasets, tables, figures, and listings to support the. statistical analysis of clinical trials .data in support of regulatory submissions and publications.
Generate SDTM domains, ADaM datasets, and Define.xml or Define.pdf files.
Perform quality control for SAS programs and other study documents (e.g., presentations and reports).
Maintain complete and auditable documentation of all programming activities.
Review output across SAS programs to ensure consistency.
Provide statistical programming support to supplemental or exploratory analyses for regulatory agencies or any other internal and external ad-hoc requests.
Assist in programming, testing, and documenting SAS global utility programs and tools in accordance with standards and validation procedures.
Participate in the development and/or maintenance of departmental procedures and standards.
Review CRFs, edit check specifications, and table mock-ups.
Works effectively with cross functional groups, study team, and vendors.
Participates in monitoring CRO activities and reviewing CRO deliverables as necessary.
May assist in creation of table, figure, or listing mockups under supervision of statisticians.
May train and mentor new programmers.
Essential Skills and Experience
SAS, SAS Macros.
FDA guidelines.
21 CFR Part 11.
CDISC data structures.
ICH guidelines.
Understanding of SDLC, Testing Process and Methodology.
Working independently and in team with minimal guidance.
Demonstrates extensive knowledge with industry standards SAS/STAT.
Knowledge on all other Microsoft programming and database Technologies is preferred.
Knowledge of SAS/Graph, SAS/SQL and SAS/ODS.
Knowledge on using Jira and other project management tools desirable.
Qualification:
Bachelor’s degree in a related field & 4 years of relevant experience required;
Note:
No of available positions for this job: 2
To apply, please send your CV’s including Job reference as subject line in your email at hr@chanit.co.uk
