Projects Portfolio
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).
Key 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 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:
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 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
Senior Programmer I/II
Purpose
The role of the Senior Programmer II is to provide programming support to the statistics and programming department across a range of projects, clients and therapeutic areas.
Key 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 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) 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 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
• Seek opportunities to develop innovative ideas, sharing when appropriate
• Line management or mentorship of more junior team members
• Contribution to development of internal training materials
• Contribution to internal process improvement initiatives
Minimum Qualification Requirements
• BSc, MSc or PhD in numerical discipline (or relevant equivalent industry experience)
• At least 4 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
Veramed is a B Corp accredited company which means that we use the power of business to build a more inclusive and sustainable economy meeting the highest verified standards of social and environmental performance, transparency, and accountability.
As an organisation that has people at the heart of it, Veramed is committed to creating a diverse environment and is proud to be an equal opportunities employer. We foster a working culture where employees have integrity, honesty and respect for one another without regard to race, national origin, religion, gender identity or expression, sexual orientation or disability. All qualified applicants will receive equal consideration for employment.