Clinical Data Manager

Responsibilities

• Create SAS codes to produce CDISC compliant datasets.
• Develop statistical analysis outputs for final reports, abstracts, posters, manuscripts, ad-hoc studies, and other clinical publications.
• Write QC SAS programs for datasets, tables, listings, and figures, adhering to departmental quality control procedures and best programming practices.
• Develop programs for ISS, ISE, and pooled datasets.
• Revise existing programs for corrections, enhancements, or system environment changes.
• Generate Pinnacle 21 reports, Define XML, Define PDFs, and Reviewers Guides.
• Review Pinnacle 21 reports for issues needing correction and ensure all errors and warnings are addressed.
• Aid in establishing standardized programming procedures and work instructions.
• Develop, enhance, evaluate, and validate standardized macros and utility programs.
• Ensure regulatory requirements are met through validation and compliance activities.
• Promote adherence to established standards, SOPs, and best practices.

Qualifications

• Proficiency in writing SAS codes to produce CDISC compliant datasets.
• Experience in developing statistical analysis outputs for various clinical publications.
• Knowledge of writing QC SAS programs for datasets, tables, listings, and figures.
• Experience in developing and revising programs for ISS, ISE, and pooled datasets.
• Ability to generate Pinnacle 21 reports, Define XML, Define PDFs, and Reviewers Guides.
• Experience in reviewing Pinnacle 21 reports for errors and ensuring their resolution.
• Knowledge of establishing standardized programming procedures and work instructions.
• Experience in developing, enhancing, evaluating, and validating standardized macros and utility programs.
• Understanding of regulatory requirements and ability to ensure compliance through validation activities.
• Strong knowledge of established standards, SOPs, and best practices.