This is a fully remote position, open to applicants in United States.

📋 Description

• Serve as the primary programmer for designated clinical trials, collaborating closely with the study statistician, clinical data management, and other team functions.

• Spearhead the strategic design, development, mapping, and validation of SDTM and ADaM datasets, ensuring comprehensive data traceability.

• Conduct statistical analyses and program as well as validate Tables, Listings, and Figures using SAS for Clinical Study Reports, Development Safety Update Reports, ad-hoc requests, and publications.

• Review and ensure the quality of CDISC packages, which include aCRF, SDTM/ADaM datasets, Pinnacle 21 reports, cSDRG/ADRG, and define XML for eCTD submissions.

• Execute additional responsibilities as assigned.

⛳️ Requirements

• Bachelor’s or Master’s degree in Statistics, Biostatistics, Computer Science, Mathematics, or a closely related scientific field.

• Over 8 years of statistical programming experience in a bio/pharma company or clinical research organization (CRO).

• Advanced skills in SAS, including complex data steps, Macro language, and commonly utilized analysis procedures such as PROC FREQ, PROC REPORT, PROC SQL, and PROC MIXED.

• In-depth knowledge of CDISC standards and experience in generating regulatory package artifacts such as define.xml and Reviewer's Guides (cSDRG, ADRG).

• Excellent communication, analytical, and problem-solving abilities, with strong time management skills and the capacity to independently handle multiple high-priority projects in a fast-paced setting.

• Exceptional interpersonal abilities and the capability to collaborate effectively as part of a cross-functional team.

• Proven track record of working independently, communicating proactively, and achieving results efficiently in a remote work environment.