Clinical SAS Programmer

Responsibilities:

8 years hands on statistical programming experience in the pharma/biotech industry

Strong SAS programming skills required, with proficiency in SAS/Base, SAS/Stat, and SAS Macros, preferrable experience using R.

Desire to understand the disease area, protocol, SAP, and study related documents.

Good knowledge of clinical trial design, and statistical terminology.

Strong knowledge of CDISC SDTM and ADaM data models.

Demonstrated proficiency in developing dataset specifications, and using SAS/R to produce SDTM datasets, ADaM datasets, and TFLs.

Thorough understanding of clinical data structures, and data exchange with multiple data formats.

Expertise in performing validation of datasets, and TFLs using risk-based approach.

Expertise in regulatory submissions, preparation of e-sub package.

In-depth understanding of regulatory, industry, and technology standards and requirements.

Exceptional organizational, communication and time management skills, with the ability to multi-task across projects.

Demonstrated ability to work in a team environment with cross-functional teams.

Requirements:

Strong SAS programming skills required, with proficiency in SAS/Base, SAS/Stat, and SAS Macros, preferrable experience using R.

Strong knowledge of CDISC SDTM and ADaM data models.

Demonstrated proficiency in developing dataset specifications, and using SAS/R to produce SDTM datasets, ADaM datasets, and TFLs.

Expertise in regulatory Submissions.