Lead Programmer (LEDC)

Fortrea; Mumbai; On-site; INR 1,400,000 - 2,100,000; Full time

Job summary

Fortrea is seeking an experienced data programming professional to lead EDC and SAS programming efforts across multiple clinical studies in Mumbai. You will mentor teams, oversee SDTM programming, and drive data quality and timely delivery.

Responsibilities include building SDTM and custom datasets, creating visual dashboards, and acting as SME for global project teams with clients and Data Managers. Strong English communication and leadership are essential.

Qualifications

• Fluent English, both written and verbal.
• Bachelor’s degree or equivalent experience in life sciences, IT, or related field.

Responsibilities

• Lead EDC builds and mentor study teams in setting up Medidata RAVE, Oracle InForm, SAS, or other software.
• Develop visual analytics dashboards using Tableau or Spotfire.
• Serve as SME on multiple projects and provide technical guidance across programming activities.
• Plan, manage, and oversee all SDTM programming across studies, including resource estimation and budgeting.
• Coordinate SDTM programmers across projects and contribute to QA and code reviews.
• Provide consultation on database design and development with Data Managers.

Skills

Team leadership

Client communication

Problem solving

Mentoring

Education

Bachelor's degree in life sciences or IT

Tools

Medidata Rave

Oracle InForm

SAS

Tableau

Spotfire

Job description

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.

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

Qualifications (Minimum Required)

• 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.
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.

Experience (Minimum Required)

• 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.
• Demonstrated ability to work in a team environment.
• Demonstrated ability to handle multiple competing priorities.
• Proven managerial and interpersonal skills.

Physical Demands/Work Environment

• Office work environment.

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