Director, SAS Programming and Data Management
Apply NowCompany: Emalex Biosciences, Inc.
Location: Chicago, IL 60629
Description:
PRIMARY ROLE:
The Director, SAS Programming and Data Management is a key member of the Biostatistics and Data Management team responsible for the oversight of data and analysis processes conducted by CROs. This individual will collaborate closely with internal colleagues to ensure data integrity and quality and CDISC dataset and TLF quality for first in human clinical trials up through NDA filing and post-marketing.
DUTIES AND RESPONSIBILITIES:
QUALIFICATIONS:
The Director, SAS Programming and Data Management is a key member of the Biostatistics and Data Management team responsible for the oversight of data and analysis processes conducted by CROs. This individual will collaborate closely with internal colleagues to ensure data integrity and quality and CDISC dataset and TLF quality for first in human clinical trials up through NDA filing and post-marketing.
DUTIES AND RESPONSIBILITIES:
- Manage CROs and other outside vendors for data management activities for clinical trials. Provide oversight and feedback related to data management operations, issues, and trends in performance.
- Acts as primary contact and accountable operational lead from data management. Coordinates with CRO to meet operational objectives.
- Manage and/or perform data management tasks in adherence with established standards including third party vendor data reconciliation, medical coding processing, protocol deviation collection, query management to identify errors and inconsistencies in clinical data and ensure their resolution.
- Provide data management input for outsourced clinical trial scope, deliverables, and coordination of internal cross functional review.
- Ensure CRO data management adherence to global and federal regulations, and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, and to data management quality standards.
- Manage CROs and other outside vendors for SAS Programming activities for clinical trials. Provide oversight and feedback related to SAS Programming issues, review of specifications, and content and format of datasets and TLFs.
- Develop SAS programs to create datasets and TLFs as assigned by manager.
- Develop SAS programs to review/QC SAS programming deliverables from CROs and other outside vendors as assigned by manager.
- Ensure CRO SAS Programming adherence to global and federal regulations, and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, CDISC standards and to biostatistics quality standards.
- SAS programming and/or other duties across the corporation as assigned by manager.
QUALIFICATIONS:
- BS or equivalent from accredited college or university, in statistics, IT, mathematics or closely related field.
- 10+ years' experience in SAS programming within the area of clinical trials.
- 5+ years' experience as supervisor/manager
- Demonstrated working knowledge of data processing, database design and organization in clinical data environment.
- Demonstrated working knowledge of basic clinical trial design and analysis principles.
- Working knowledge of CDISC standards and application of these standards to projects.
- Working knowledge and understanding of advanced statistical concepts to program analysis datasets and tables which include descriptive and standard/complex inferential statistics.
- Strong computer skills, with evidence of advanced SAS programming skills.
- Ability to support Biostatisticians with advanced statistics.
- Advanced knowledge of SAS Software data set architecture, utilities, and programming techniques.