LEAD PROGRAMMER

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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.
Summary of Responsibilities 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 makes 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 consultation in the area of database design and development with Data Managers.
Provide expert technical guidance to project teams, external and internal clients within a global setting. Assist in developing and maintaining data loading procedures.
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.
Mentor and aide in staff development and achievement of competence standards, regulations pertaining to computerized systems to projects to ensure compliance.
Oversees 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.
Conducts team meetings, provides technical guidance/assistance to Programmers, and perform other duties as assigned by Manager.
University / college degree (life sciences, health sciences, information technology or related subjects preferred).
Experience and/or education plus relevant work experience, equating to a bachelor's degree will be accepted in lieu of a bachelor's degree.
Fluent in English, both written and verbal.
6 to 9 years of relevant work experience to include data management and/or database programming activities including three years Medidata Rave, Oracle InForm, or equivalent experience or SAS Programming or Spotfire or Tableau experience.
Demonstrated skill in leading teams, by example and mentoring staff.
Excellent oral and written communication and presentation skills.
Knowledge of clinical trial process and data management, CRF design, and systems applications to support operations.
Working knowledge of the relationship and regulatory obligation of the CRO industry with pharmaceutical/biotechnological companies.
Mid‐Senior level
Full‐time
Information Technology
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