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.

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

Did you know?  

Labcorp’s Clinical Development and Commercialization Services business is now  Fortrea in connection with its planned spin-off from Labcorp, which is expected in mid-2023. Fortrea’s spin-off from Labcorp is subject to satisfaction of certain customary conditions. This spin-off will position both organizations for accelerated growth and allow each to focus resources on distinct strategic priorities, customer and employee needs and value creation opportunities. As a provider of phase I-IV clinical trial management, regulatory guidance, patient access solutions and market access consulting, Fortrea will partner with both emerging and large pharmaceutical, biotechnology, device and diagnostic companies to drive healthcare innovation and improve the lives of patients worldwide.

Fortrea is looking for problem-solvers and creative thinkers who are passionate about breaking down barriers faced by sponsors of clinical trials, and who are committed to helping transform the development process to get promising life-changing ideas and therapies to patients faster. Join us as we cultivate a workspace where all employees have the opportunity to grow and make impacts on a global scale.

Labcorp is proud to be an Equal Opportunity Employer:

As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

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