Job Description

Target Pay Rate: 75-90/hr **salary will be commensurate with experience 

Job Description:

• Review and ensure accurate and high-quality statistical programming deliverables from CRO

• Perform generation, validation and QC/QA of SDTM, ADam and TFL output in accordance with SOPs, SOIs, and guidance documents.

• Create and maintain specifications as per SDTM/ADaM standard and study SAP.

• Define and create ad-hoc reports and listings for clinical teams.

• Develop, implement and maintain SAS programming standards.

• Builds/tests programs for Data Validation, Derivation, and Data Reports to identify inconsistencies and support data review efforts, as necessary.

• Verifies completeness of relevant study deliverables prior to release from the group

• Maintains all required study documentation.

• Consults and provides input into system validation efforts including tool maintenance activities.

• Ensure CRF meets the guidelines of the protocol and check for consistency and adequacy.

• Work in tandem with Biostatistics and Data Management member on various clinical projects.

• Review CRF annotations and data specifications.

• Perform quality control on final reports.

• Develop SAS coding and table templates for preparing, processing and analyzing clinical data.

• Establish monitoring of data transfers for ongoing trials to identify study conduct or data quality issues.

Skills:

• Develop SAS coding for generating SDTM, ADaM datasets and TLFs to support clinical study analysis.
• Perform clinical study report and/or exploratory analysis for oncology clinical study.
• Perform validation of ADaM datasets and TLFs per SAP.
• Effectively review and comment on vendor programming deliverables and help resolve technical difficulties. 
• Proficient computer skills across multiple applications and OS environments.
• Oncology experience is highly preferred.

Education:

• BS or above in computer science/statistics with at least 5 years of SAS experience in major pharma or CRO.

**CO/NY candidates may not be considered 

Job Tags

Remote job, Contract work,

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