Senior/ Principal Programmer (SAS & R)

Responsibilities

• The job tasks listed below outline the scope of the position. The application of these tasks may vary, based on current business needs.
• 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 & R 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 & R, 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, programmer s 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:
• o Being Veramed Project Manager on client accounts and projects
• o Maintain the project plan
• o Proactive management of resource, scope change and risks
• o Manage the delivery of projects to budget
• o 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 & 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
• Senior Programmer I/II
• Purpose
• The role of the Senior Programmer I/II is to provide programming support to the statistics and programming department across a range of projects, clients and therapeutic areas.
• The job tasks listed below outline the scope of the position. The application of these tasks may vary, based on current business needs.
• Technical:
• Perform consistency review of clinical trial documents including protocols, SAPs, CRFs, CSRs
• Author and review simple and complex study TFL shells
• Author and review simple and complex dataset standards
• Perform data checks and data exploration (e.g. using frequencies, histograms)
• Program and QC routine and ad hoc datasets and TFLs (in SAS & R) following specifications, applying good programming practice
• Complete and review CDISC Validation tool reports
• Ensure the appropriate standards are being applied and adhered to
• Familiarisation with simple statistical techniques (e.g. t-test, ANOVA, regression, standard survival)
• Review of project management related documents
• Maintain study master file documents and any other documents that are required to be audit ready
• Project Management:
• Act as Lead Programmer and/ or Veramed Project Manager for client projects and studies
• 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 team meeting

Additional Information

Principal Programmer 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).

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Company Intel

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