Responsibilities :
- Perform SAS programming activities to meet timelines, budget, and quality in accordance with Company study contracts and SOPs.
- Effectively work with Biostatisticians and Statistical Programming team to review data specs, generate or QC analysis datasets and generate or QC analysis outputs per requests for internal medical monitoring, CSR, and submission needs.
- Work with data managers to generate ongoing outputs to support data cleaning and to enhance data integrity.
- Communicate effectively within Biometrics and with cross-functional team members.
- Provide programming expertise to review / QC the programming work provided by the CRO including QC outputs, datasets, and programming related documents;
debug programming errors as needed.
- Work on special projects as needed.
- Support internal analysis data and reporting deliverables. Ensure timely, targeted, and accurate reporting and outcomes.
- Develop or QC and document Statistical Programming team macros.
- Ability to work within a team as well as independently.
- Ability to lead a programming deliverable as needed.
Requirements :
- Bachelor's Degree in statistics, computer science or another related science field with a minimum of years of SAS programming experience with clinical trial data OR master's degree in statistics, computer science or another related science field with a minimum of years of SAS programming experience with clinical trial data.
- Good working knowledge of CDISC SDTM and Adam Implementation Guidelines.
- General knowledge of regulatory requirements and drug development process.
- Strong verbal and written communication skills.
- Ability to work independently as well as part of programming teams.
- Strong communication skills set with peers and other group partners.
- Consistently deliver high quality deliverables on time and meet the project delivery expectation.
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