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Job Description:
Major Tasks of Position:
- Understanding of clinical trial objectives, design, endpoints and procedures defined in Protocol and Statistical Analysis Plan (SAP).
- Develop programs that convert raw SAS datasets into standard format and improve existing programs by creating standard programs and macros.
- Collaborate with manager and other programmers through participation in formal and ad-hoc meetings.
- Assist manager through contributions to continuous improvement by developing standard programs and macros that follow CDISC guidelines required for regulatory submissions.
- Independently program CDSIC SDTM, ADaM datasets.
- Map raw data to SDTM (Study data table model) in compliance with CDISC data model standards and create specifications for programming.
- Create ADaM Specifications & datasets from SDTM datasets per CDISC analysis data model standards and SAP.
- Provide validation support to create SDTM+, SDTM and/or ADaM datasets / TLFs & documentation as per the specifications within set timelines
- Program data displays (tables, listings, graphs) for inclusion in documents including publications, statistical reports, clinical study reports, and other regulatory documents, as required.
- Independently develop QC programs to validate peer programmers’ SDTM, ADaM datasets, statistical tables, listings, and graphs
Requirements: - Demonstrate proficiency of programming skills. Must have exp of ONC and efficacy programming.
- In-depth knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
- Strong Base SAS v9.2 or later; SAS-STAT, and SAS Macro experience.
- Ability to work on multiple tasks and prioritize tasks.
- Excellent analytical, problem-solving, organizational, time management, interpersonal and communication skills.
- QC experience.
Work Interactions: - Early Clinical Leaders / Global Clinical Leaders
- Global Safety Leaders/ Data managers
- Statisticians and Statistical Analysts
Qualifications: - Bachelor’s degree in Computer Science, Statistics, Engineering or related field with minimum 6 years of related experience.
- Required skills: create SDTM datasets from raw data according to CDISC standards; Create ADAM datasets from SDTM datasets according to CDISC analysis data model standards; Independently write, test, run, document, maintain and QC SAS programs and macros to generate SAS datasets, spreadsheets, data listings, tables and graphical displays of clinical trials data;
- Prior experience working with Data Management on edit checks etc is preferred Good knowledge of statistical programming languages (including SAS)
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