Bernice Yost Email & Phone Number

Collegeville, Pennsylvania

• Advised Clinical Teams on developing Therapeutic Area Data Standards. Researched and resolved all requests for additions/changes/exceptions to the approved standards.
• Submission Data Standards team member on mapping current Wyeth databases into the CDISC SDTM (Study Data Tabulation Model) which resulted in efficiency and accuracy when completing an FDA submission.
• Trained/guided programmers in determining the correct SDTM mapping for Therapeutic Area projects/protocols which improved speed and efficiency for the programmers.
• Selected from all other programmers to work in the data standards department due to thorough understanding of the clinical trials data process.
• Maintained the Pfizer/Wyeth data safety standards in alignment with the CDASH requirements for standard data entry screens which delivers increased efficiency through the data management and programming tasks.
• Merged Wyeth data standards (Data Lifecycle Package – DLP) into Pfizer standards for Safety and Therapeutic Area Specific data to improve the Pfizer Standards.

Collegeville / Radnor, Pennsylvania

• Associate Director 2005 - 2007Assistant Director 2003 - 2005Therapeutic Area Supervisor / Manager 2001 - 2003Managed and guided technical personnel (up to 8 direct reports) in the analysis, design, programming.
• Collaborated closely with Medical Personnel, Data Management, Biostatisticians, Clinical Writers, and Regulatory to determine appropriate format and content of data collection and data reports.
• Successfully completed many submissions on time for drug approval to the FDA (Federal Drug Administration), EMA (European Medicines Agency), Health Canada, PMDA (Japan - Pharmaceuticals and Medical Devices Agency), and.
• Chairperson of the View Review Team which verified the correct database structure and derived data algorithms for all new types of data across all therapeutic areas.
• Coordinated the Programming Training Initiative Team (PTI) which successfully developed a training program that reduced the training time to less than one year for a fully trained and independent productive programmer.
• Developed new department SOPs which improved efficiency and accuracy.

Radnor, Pennsylvania

• Senior IT Engineer Applications 1999 - 2001IT Engineer Applications / Senior Programmer Analyst B 1996 - 1999Programmer Analyst A 1989 - 1996Programming Team Lead analyzed, designed, programmed, validated, and.
• Analyzed and designed how to improve the data quality and successfully implemented the solution.
• Developed a new data algorithm to improve Non-Study Medication data mining.

Devon, PA

Designed, coded, integrated, tested, and supported system software for an international data communications network. Supervised software troubleshooting and maintenance at customer sites.

Ba, Biology

Master'S, Computer Science