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Principal Programmer
2 weeks ago
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
