Principal Clinical Programmer/Lead Programmer

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GSK Clinical Programming brings together some of the most talented minds to engage in advanced data analytics, principles of data science, and developing new computational tools to support innovative research and develop novel therapies. We serve five key therapeutic areas: HIV, Immunology, Infections Disease, Oncology, Respiratory, and Vaccines, and offer unlimited growth opportunities and exciting career paths for a wide range of experience levels.

Your Role:

Principal Clinical Programmer/Lead Programmer role at GSK reports into the associate director or research unit head. Principal 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 Clinical Programmer/Lead Programmer 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.

• Acts as a subject matter expert and works as a lead within own discipline to investigate new technology as directed

• 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 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

• Able to understand and clarify boundaries of responsibility within own role; allocates decision making authority and task responsibility to others as appropriate.

Why you?

Qualifications & Skills:

We are looking for professionals with these required skills to achieve our goals:

• 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

• Advanced macro development and debugging, and executing complex programming activities skills

• Strong expertise in CDISC standards and its application

• Strong knowledge of Good Practice (GxP), and International Council for Harmonization (ICH) requirements

Preferred Qualifications & Skills:

If you have the following characteristics, it would be a plus:

• Solid understanding of the pharmaceutical regulatory and publishing processes (e.g., 21 CFR Part 11)

• Expertise in therapeutic area specific requirements – Oncology experience preferred

• 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.)