Lead Programmer

Overview

Lead Programmer responsible for EDC build and configuration, SDTM/SAS programming, and technical leadership of study teams, acting as subject matter expert and liaison for assigned projects.

What you'll do

• 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 and validate custom/complex SDTM/SAS datasets, listings and reports.
• Efficiently handle external data and data reconciliations.
• Configure and implement EDC services within the scope of assigned projects to achieve project integrity and on-time, quality data delivery.
• 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 dashboards using tools such as Spotfire or Tableau.
• Function as subject matter expert and lead on multiple projects.
• Plan, manage, execute and oversee all SDTM programming activities across multiple studies.
• Coordinate activities of all SDTM programmers across projects and provide technical/functional expertise and statistical programming decisions/recommendations at study or project level.
• Develop and validate custom/complex edit-check programs, reports and SDTM domains.
• Plan, execute and oversee all programming activities on a study, including resource estimation, working within budget, meeting timelines, maximizing quality, and interacting with other departments and the client.
• Perform lead/code review to ensure quality deliverables to clients.
• With assistance, meet with Data Managers to discuss technical strategies, contractual obligations and timelines, and provide information on resource needs.
• Provide consultation on database design and development with Data Managers.
• Participate in ongoing review of processes to adopt best practices.
• Provide expert technical guidance to project teams and internal and external clients in a global setting.
• Assist in developing and maintaining data loading procedures.
• Maintain awareness of new developments in EDC products, standards and tools.
• Serve as initial point of contact for programming on a project and assist interns and programmer analysts in complex issue troubleshooting, documentation and adhering to standards.
• Participate in sponsor meetings and audits/inspections.
• Mentor and aid in staff development and achievement of competency standards, and ensure compliance with regulations pertaining to computerized systems.
• Oversee the project work of technical and design staff and manage projects within assigned budgets.
• Notify project leadership of out-of-scope work requests and advise management of scope changes to enable timely change orders.
• Participate in developing global, harmonized SOPs and quality work instructions for technical service group activities.
• Provide support and troubleshooting of EDC and act as study team liaison.
• Prepare and provide internal training on advanced topics with Senior Management.
• Conduct team meetings and provide technical guidance to programmers.
• Participate in business development presentations and bid development.
• Perform other duties as needed or assigned.

What you'll need

• University or college degree in life sciences, health sciences, information technology or related subjects, or experience and/or education plus relevant work experience equating to a bachelor's degree; Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
• Fluent in English, both written and verbal.
• 6 to 9 years of relevant work experience in data management and/or database programming activities, including three years of Medidata Rave, Oracle InForm, or equivalent experience, or SAS programming, or Spotfire or Tableau experience.
• 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 obligations of the CRO industry with pharmaceutical and biotechnology companies.
• Demonstrated ability to work in a team environment and handle multiple competing priorities.
• Proven managerial and interpersonal skills.

Details

• Location: Bangalore.
• Physical demands/work environment: office work environment.