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Remote, 12-month contract with potential to renew long-termStatistical Programming & Deliverables
- Develop and review programming components for CRFs, SAPs, analysis dataset specifications, and TFL shells.
- Program and validate analysis datasets and TFLs to support NDAs, sNDAs, integrated summaries, and post submission requests.
- Convert, clean, verify, and integrate multiple incoming data sources for analysis dataset creation.
- Generate rapid, ad hoc analyses in response to clinical or statistical inquiries.
- Ensure all programming deliverables meet quality, regulatory, and timeline expectations.
Standards, Tools & Compliance
- Apply and ensure adherence to industry standards, including CDISC (SDTM and ADaM) and Define XML.
- Contribute to the development, maintenance, and validation of departmental programming tools and macros.
- Maintain documentation to audit ready standards in accordance with internal SOPs and regulatory guidelines.
Collaboration & Cross Functional Support
- Partner with Biometrics, Clinical Operations, Regulatory Affairs, and Clinical Development.
- Provide input into clinical database design to optimize data capture and ensure data quality.
- Support a collaborative, team focused culture.