Principal Programmer

3 days ago

Bengaluru, India Veramed Data Services Full time

Purpose

The role of the Principal Programmer is to provide programming support to the statistics and programming department across a range of projects, clients and therapeutic areas. The Principal Programmer may also perform a supervisory role (e.g. line management and/or project management).

Key Responsibilities

  • Supporting with CDISC implementation of studies with Real world data QC of SDTM/ADaM datasets as required
  • Review the aCRF, Specs, relevant documentation like SDRG/ADRG, as relevant
  • Expertise working across different disease areas like Oncology, Vaccines, Respiratory etc Guide Real World Programmers on NIS with CDISC expectations

Technical:

  • Perform review of clinical trial documents including protocols, SAPs, CRFs, CSRs
  • Author, review and approve study TFL shells and dataset specifications
  • Author, validate and document SAS programs for datasets, TFLs and macros, applying good programming practice
  • Identify data issues and outliers
  • Complete, review and approve CDISC Validation tool reports
  • Identify data and standards issues and resolve or escalate as appropriate
  • Awareness of emerging standards and associated impact to ongoing and future planned trials
  • Maintain proficiency in SAS and awareness of developments
  • Maintain study master file documents and any other documents that are required to be audit ready

People Management:

  • Line management of statisticians, programmers and other technical staff. Accountable for overall performance of direct reports
  • Provide coaching and mentoring of staff to achieve excellence. Direct employee career development and ensure line reports receive appropriate training to perform their day-to-day jobs
  • Interview and effectively on-board and integrate new staff members
  • Provide programming technical leadership and coaching

Project Management:

  • Oversight of key client projects/portfolios. To include:
  • Being Veramed Project Manager on client accounts and projects
  • Maintain the project plan
  • Proactive management of resource, scope change and risks
  • Manage the delivery of projects to budget
  • Manage client expectations and issue resolution

General:

  • Lead internal and client study, project and cross functional team meetings effectively
  • Present study updates internally and at client meetings
  • Share scientific, technical and practical knowledge within the team and with colleagues
  • Perform work in full compliance with applicable legislation, regulations, company policies, procedures, and training
  • Build effective collaborative working relationships with internal and client team members
  • Ensure learnings are shared across projects or studies
  • Develop and provide internal technical training where appropriate
  • Lead process improvement initiatives

Minimum Qualification Requirements

  • BSc, MSc or PhD in numerical discipline (or relevant equivalent industry experience)
  • At least 8 years of relevant industry experience

Other Information/Additional Requirements

  • Understanding of clinical drug development process, relevant disease areas, endpoints and study designs
  • Awareness of industry and project standards & ICH guidelines
  • Excellent verbal and written communication skills
  • Interpersonal/teamwork skills for effective interactions
  • Proficiency in data handling using SAS or other statistical software (e.g. R)
  • Self-management skills with a focus on results for timely and accurate completion of competing deliverables
  • Demonstrated problem solving ability and attention to detail
  • Ability to work independently and as part of a team
  • Ability to manage a portfolio of projects and/or people

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