Lead Clinical SAS Programmer

Job Overview

Assist in the development and implementation of solutions to global technical service issues and concerns regarding EDC or SAS or other proprietary software, including proactive prevention strategies. Develop/validate Custom/Complex SDTM/SAS datasets/Listings/reports. Efficiently handle external data and data reconciliations. Responsible for configuration and implementation of EDC services within the scope of assigned projects to achieve project integrity and the delivery of on-time, quality data.

With some support act as technical liaison with project team members, clients, and Data Managers to drive the technical aspects of project delivery.

• Expected to assist with leading EDC Builds and mentor the study team in setting up Medidata RAVE or Oracle InForm or SAS or other proprietary software.
• Lead the development of visual analytics dashboard using tools like Spotfire/Tableau.
• Functions as Subject Matter Expert (SME) and Lead on multiple projects.
• Assist in the development and implementation of solutions to global technical service issues and concerns regarding EDC or SAS or other proprietary software, including proactive prevention strategies.
• Assist with the development of training programs to ensure staff, project and technical, achievement of position competencies.
• Plan, manage, execute, and oversee all SDTM programming activities across multiple studies.
• Co‑ordinate activities of all SDTM programmers across projects and provide technical/functional expertise and make statistical programming decisions/recommendations at study or project level.
• Develop/validate Custom/Complex Edit‑Check programs, reports, SDTM domains and efficiently handle external data and data reconciliations.
• Plan, execute and oversee all programming activities on a study, including but not limited to resource estimation, working within budget, meeting timelines, maximizing quality, interaction with other departments and the client, etc.
• Perform Lead/Code review to ensure quality deliverables to clients.
• With assistance meet with Data Manager on assigned projects to discuss technical strategies, contractual obligations, and timelines. Provide information on resource needs as appropriate.
• Provide consultation in the area of database design and development with Data Managers.
• Participate in the ongoing review of the processes used to ensure adaptation of best practices.
• Provide expert technical guidance to project teams, external and internal clients within a global setting. Assist in developing and maintaining data loading procedures.
• Maintain awareness of new developments in EDC products / Standards / tools which may be applied to improve the efficient use of these systems.
• Take initiative to accept new challenges in programming. As a SME be initial point of contact for programming for a project and assist Interns and Programmers Analysts in complex issue troubleshooting, documentation and adhering to Standards.
• Follow attention to detail approach and participate in sponsor meetings and audits/inspections.
• Mentor and aide in staff development and achievement of competency standards, regulations pertaining to computerized systems to projects to ensure compliance.
• Oversee the project work of technical and design staff. Manage projects within the scope of assigned budgets.
• Notify project leadership of requests for out‑of‑scope work and advise management of changes in scope of projects to enable the timely development of change orders.
• Participate in the development of global, harmonized SOPs and specific quality work instruction for technical service group activities provide support, troubleshooting of EDC, and act as the study team liaison.
• Prepare and provide internal training on advanced topics as needed in conjunction with Senior Management.
• Conduct team meetings, provide technical guidance/assistance to Programmers, and perform other duties as assigned by Manager.
• Participate/Assist in the Business Development presentations and bid development.
• Perform any other duties as needed or assigned.

• University / college degree (life sciences, health sciences, information…