Review & annotate eCRFs, data management plan, edit check specifications, & statistical analysis plan, to ensure that data can be appropriately analyzed.

Monitor the status of projects to ensure that they are progressing according to schedule and identifying potential problems that may affect the project's outcome.

Review & ensure statistical programming deliverables & support electronic regulatory submission to FDA.

Perform generation, validation, and Quality Control/Quality Assurance of SDTM, ADaM and TFL output in accordance with SOPs & guidance documents.

Create and maintain specifications as per CDISC SDTM/ADaM standards and use SAP.

Develop, implement, and maintain SAS programming standards, define & create ad-hoc reports and listings for clinical teams.

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

Maintain knowledge of new technologies and techniques in their field of expertise.

Develop SAS coding and table templates for preparing, processing, and analyzing clinical data; Ensure compliance of clinical datasets by running P21 validator and document issues.

Generate & review submission documents using define.xml & reviewers guide (SDRG) and (ADRG).

Test RAVE/ MEDIDATA EDC databases including dictionaries, data validation checks, database functions, standard and custom database reports.

Monitor data transfers for ongoing trials to identify study conduct or data quality issues.

Position Requirements: Bachelor's degree or a foreign equivalent degree in Healthcare Informatics, Health Admin, Pharmacology, Toxicology, Pharmacy, Chemistry, Computer Science, Bio Informatics, Bio Technology, Statistics or related field plus five years of progressive work experience in any position/title providing experience with SAS.

Special Skills: Qualifying experience must include experience with SAS.

Position requires travel/relocation to various unanticipated client locations throughout the U.S. with expenses paid by the employer.

Benefits: Medical, Life Insurance and 401K.

Standard Company Benefits.