Lead Programmer-Remote

The Lead Programmer is 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.

What to Expect

• 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 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.
• 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, provide technical guidance/assistance to Programmers and perform other duties as assigned by Manager.
• Participates/Assists in the Business Development presentations and bid development.

Education/Qualifications

• 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.

Experience

• From 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.
• Demonstrate excellent problem solving skills, a proactive approach and the ability to make sound decisions.
• 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.

US Pay Range: $85,000-$130,000

Benefits: All job offers will be based on a candidate's skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data. Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(K), ESPP, Paid time off (PTO) or Flexible time off (FTO), Company bonus where applicable. For more detailed information, please click here.

As a leading contract research organization (CRO), Labcorp Drug Development provides comprehensive drug development solutions for a range of industries. Our services cover the preclinical, clinical and post-market phases of drug development, the product life cycles for medical device and diagnostics and development services paired with regulatory support for the chemical testing and crop protection industries.

Labcorp Drug Development is a global leader in nonclinical safety assessment, clinical trial testing and clinical trial management services. Our unique perspectives are based on decades of scientific, medical and regulatory expertise.

In July 2022, Labcorp announced its intention to spin off its clinical development business as a separate public company, subject to the satisfaction of certain customary conditions. Fortrea will become the new brand identity for our Clinical Development business in connection with the spin-off, which is expected in mid-2023.

We believe that the exceptional is possible when you have the right partner, so we are looking for the right people to help build a transformative force in Clinical Development. www.fortrea.com

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