Lead Programmer – LEDC

Jobtailor

Bengaluru

On-site

INR 1,500,000 - 3,000,000

Full time

3 days ago

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Job summary

Jobtailor seeks an experienced clinical programming professional to lead SDTM programming, EDC builds and analytics development. The role requires hands-on expertise in Medidata RAVE, Oracle InForm, SAS, Spotfire/Tableau and mentoring study teams.

You will manage multiple studies, coordinate programmers, ensure quality deliverables, and engage with clients and data managers in a global setting. Office-based role in Bengaluru, with cross-functional collaboration.

Qualifications

Bachelor's degree or equivalent experience in life sciences, health sciences, IT, or related field
5+ years of experience in data management or database programming in clinical trials
Experience with Medidata RAVE, Oracle InForm, SAS, Spotfire or Tableau is required

Responsibilities

Assist in developing and implementing solutions to global technical service issues involving EDC, SAS, and proprietary software
Lead or assist with EDC builds and mentor study teams using Medidata RAVE, Oracle InForm, SAS, or proprietary software
Develop visual analytics dashboards using Spotfire or Tableau
Serve as SME and lead across multiple projects
Plan, manage, execute, and oversee SDTM programming activities across multiple studies
Coordinate SDTM programmers and provide technical/functional expertise and programming recommendations
Develop and validate custom/complex edit-check programs, reports, SDTM domains, and reconciliations
Oversee study programming, resource estimation, budgets, timelines, quality, departmental interaction, and client interaction
Perform lead and code reviews to ensure quality deliverables
Collaborate with Data Managers on technical strategies, contractual obligations, timelines, resource needs, database design, and development
Provide technical guidance to project teams, clients, and internal stakeholders in a global setting
Develop and maintain data-loading procedures
Monitor developments in EDC products, standards, and tools
Troubleshoot complex programming issues and support interns and programmer analysts
Participate in sponsor meetings, audits, inspections, SOP development, quality work instructions, and training
Oversee technical and design staff and manage projects within assigned budgets
Notify leadership of out-of-scope work and changes in project scope
Conduct team meetings and provide technical guidance to programmers
Participate in business development presentations and bid development
Perform other assigned duties

Skills

EDC Build Management

SAS Programming

Spotfire Dashboard Development

SDTM Programming

Team Leadership

Education

Bachelor's degree in life sciences or IT

Tools

Medidata RAVE

Oracle InForm

Spotfire

Tableau

Job description

Assist in developing and implementing solutions to global technical service issues involving EDC, SAS, and proprietary software
Lead or assist with EDC builds and mentor study teams using Medidata RAVE, Oracle InForm, SAS, or proprietary software
Develop visual analytics dashboards using Spotfire or Tableau
Serve as SME and lead across multiple projects
Plan, manage, execute, and oversee SDTM programming activities across multiple studies
Coordinate SDTM programmers and provide technical/functional expertise and programming recommendations
Develop and validate custom/complex edit-check programs, reports, SDTM domains, and reconciliations
Oversee study programming, resource estimation, budgets, timelines, quality, departmental interaction, and client interaction
Perform lead and code reviews to ensure quality deliverables
Collaborate with Data Managers on technical strategies, contractual obligations, timelines, resource needs, database design, and development
Provide technical guidance to project teams, clients, and internal stakeholders in a global setting
Develop and maintain data-loading procedures
Monitor developments in EDC products, standards, and tools
Troubleshoot complex programming issues and support interns and programmer analysts
Participate in sponsor meetings, audits, inspections, SOP development, quality work instructions, and training
Oversee technical and design staff and manage projects within assigned budgets
Notify leadership of out-of-scope work and changes in project scope
Conduct team meetings and provide technical guidance to programmers
Participate in business development presentations and bid development
Perform other assigned duties

Requirements

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
Relevant and equivalent experience may be considered in lieu of educational requirements
Fluent in English, both written and verbal
6 to 9 years of relevant work experience, including data management and/or database programming activities
Three years of Medidata Rave, Oracle InForm, or equivalent experience, or SAS Programming or Spotfire or Tableau experience
Excellent problem-solving skills and a proactive approach
Ability to make sound decisions
Demonstrated skill in leading teams 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
Ability to work in an office work environment

Core Competencies

Demonstrates expertise in EDC, SAS, and proprietary software solutions, with a strong focus on SDTM programming, data management, and visual analytics using Spotfire or Tableau. Proven ability to lead teams, mentor staff, and manage projects effectively within the clinical trial process.

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