Founded by Ernest Pineda Gerard Group, Inc., is a niche provider of staffing solutions to leading pharmaceutical, biotechnology, finance, banking, marketing and healthcare companies. Gerard locates, qualifies and places highly skilled consultants to its clients on a nationwide basis. The Company provides professionals in biostatistics, statistical programming, data management, drug safety, medical writing, risk analysis, marketing, outcomes research and utilization. Focused on quality and responsive service, the Gerard Group delivers the skilled professionals its clients need to more quickly and efficiently get their products to market. In addition to full time hourly contractors Gerard also provides our clients with candidates on a contract to hire and full time employment basis.JOB DESCRIPTION
Candidate will provide statistical programming support to clinical trials for regulatory submission. Support Data Management in data set creations/transfers, integrity checks, and quality audits. Support Biostatistics in statistical analysis, including generating data listing, tables, and figures for clinical trials. Develop and maintain the infrastructure for project files of SAS datasets and SAS codes. Act as a liaison between clinical and subcommittees and project teams on an as-needed basis. Requirements
PRIMARY RESPONSIBILITIES:
- Perform or oversee team in performing all SAS programming required for clinical trial analysis and reporting.
- Provide statistical programming expertise for project teams.
- Actively participate in developing the Statistical Analysis Plan.
- Design/develop SAS macros and other utilities to expedite SAS programming activities.
- Generate tables, listings, and graphs per protocol, Statistical Analysis Plan, and/or approved client request.
- Participate in statistical program validation and quality control activities.? Actively participate in study team meetings.
- Interact with other departments, such as Clinical Operations, Project Management, and Data Management to ensure a high level of client satisfaction through successful execution of projects.
- Participate in review process of study documents such as the CRF, edit specifications written by Data Management, and Statistical Analysis Plans.
- Program data cleaning checks, as necessary, to facilitate Data Management’s data cleaning activities.
- Participate in installation/validation of statistical software packages throughout the software development lifecycle.
- Develop and maintain the infrastructure for project files of SAS datasets and SAS codes.
- Mentor entry level statistical programmers.
- Ensure all programming activities and processes performed are conducted according to SDC’s standard procedures and/or sponsor requirements.
- Adhere to all aspects of the SDC’s quality system.
- Comply with SDC’s data integrity & business ethics requirements.
- Perform other related duties incidental to the work described herein.
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