Site Name: USA - Pennsylvania - Upper Providence, UK - Hertfordshire - Stevenage, UK - London
Posted Date: Oct 18 2024
Your Role at GSK
The Principal Clinical Programmer role at GSK reports into the associate director or research unit head. Principle Programmers are expected to possess strong technical and excellent communication skills. They are able to identify programming and/or process related gaps and problems and provide logical and analytical solutions to address these. They are experts in their TA-specific domains and are able to provide technical and domain area specific training to their colleagues. They represent the programming team, their study, or therapeutic area cross-functionally and act as the key point of contact for programming related queries. They are expected to demonstrate strong technical and/or study lead programmer skills, engage in external organizations, and successfully work with global teams.
Principal Programmers act as the study lead programmer and offer significant contributions towards the planning and execution of multiple programming activities for GSK clinical trials. They are accountable for creating, verifying, and documenting analyses of clinical data while adhering to study protocols, analysis plans and GSK / industry standards for themselves and their team. Principal programmers are expected to participate in or lead capabilities and non-project initiatives, present at internal forums, and learn new programming languages. They interact with non-programming team members and represent their study during and function in core study team meetings.
- Completes programming activities under supervision
- Reads and understands specifications to implement them in code
- Acts as a subject matter expert and works as a lead within own discipline to investigate new technology as directed
- Provides technical contribution to complex tasks
- Ensures the collection of programs/outputs and issues are adequately managed for programming activities to achieve business outcomes
- Applies learning from previous activities to result in quicker and more efficient completion of the current task
- Shares learnings with peers and contributes to internal technical discussions/forums
- Initiates new directions and novel strategies to achieve department goals
- Identifies gaps in current programming practices and provides possible resolution suggestions
- Effectively communicates technical and complex approaches to peers and non-technical colleagues
- Project manages or leads programming activities under supervision, to achieve technical or business outcomes within own discipline
- Contributes to and influences the strategic planning and direction of a project
- Contributes to department strategies and key initiatives through working groups and sub teams
- Anticipates problems within discipline, proactively uses own expertise and/or seeks input from others, to recommend solutions and influence appropriate change
- Uses technical expertise to provide innovative solutions to project related problems of colleagues and of other projects within the research unit
- Makes decisions on the implementation of programming requirements for low-risk topics of work and can propose solutions for higher risk activities
- Contributes to the development or improvement of departmental policies and working practices
- Develops responses to audit/inspection questions and complete CAPAs within agreed timelines
- Demonstrates appropriate engagement with outsourced partners. Performs and documents oversight of outsourced activities including Quality Assurance (QA)
- Identifies and addresses issues with assigned activities and works to develop solutions with internal teams and/or outsourced partners
- Effectively presents at internal forums and/or external professional industry meetings
- Demonstrates effective communication to outsourced partners on project deliverables
- Works effectively and proactively in multi-disciplinary teams and a matrix environment through effective listening and active participation in challenging discussions
- Demonstrates networking skills through interactions across departments and divisions
- Self-awareness of development needs and proactively identifies opportunities to support development objectives
- Able to understand and clarify boundaries of responsibility within own role; allocates decision making authority and task responsibility to others as appropriate
- Acts as a mentor or coach for new and junior staff members
Minimum Qualifications:
- A BSc, BA or equivalent in Mathematics, Statistics, Computer Science, or related subject
- Statistical programming and some level of lead experience in clinical R&D is required.
- Advanced proficiency in one or more programming languages, such as R, Python, and/or SAS
- Experience with using other clinical data analysis and reporting tools, such as Spotfire, SAS Azure, or S-Plus
- Experience working with R language to produce ADaM datasets and TLGs
- Advanced macro development and debugging, and executing complex programming activities skills
- Experience using standard macro development process
- Experience in CDISC standards and its application
- Good Practice (GxP), and International Council for Harmonization (ICH) requirements experience
- Experience with Microsoft Office software (MS Word, Excel, PowerPoint, Outlook)
- Experience with submission activities and related documentation
Preferred Qualifications:
- MSc or PhD (or equivalent) in Mathematics, Statistics, Computer Science or related subject preferred
- Solid understanding of the pharmaceutical regulatory and publishing processes (e.g., 21 CFR Part 11)
- Advanced expertise in end-to-end clinical trial process and application of key clinical documents
- Expertise in Oncology therapeutic area specific requirements
- Very effective written, and verbal communication skills
- Experience with mentoring and supervising junior programmers on technical tools and concepts
- Experience with outsourcing of statistical programming work in the clinical trials setting (e.g., working with CROs, academic institutions, etc.)
- Expertise in representing programming function in cross-functional meetings, initiatives, and working group
- Strong interest in or experience contributing to external organizations (e.g., PHUSE, PharmaSUG, etc.)
- Experience with working within a global team and managing expectations across different time zones
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