Biomarker Principal Programmer/Analyst
- Stevenage, United Kingdom
Site Name: UK - Hertfordshire - Stevenage, USA - Pennsylvania - Philadelphia, USA - Pennsylvania - Upper Providence
Posted Date: Jan 7 2021
Are you a clinical programmer interested in furthering your career? If so, this Biomarker Principal Programmer Analyst role could be an ideal opportunity to explore!
GlaxoSmithKline is one of the world's foremost pharmaceutical and healthcare companies, with statisticians and programmers working in Research and Development with a global footprint spanning the UK, US, Canada and India. The Biostatistics division includes a Clinical Programming department, covering all phases of clinical drug development and commercialization in a wide range of therapeutic areas. Programming's deliverables form the core of all regulatory submissions, health authority assessments, safety updates and publications (for peer review journals and scientific meetings).
In recognition of the developing sophistication and technical requirements of the role, Clinical Programming was formed as a standalone department distinct to Clinical Statistics. Programming asset teams are now stepping up to achieve the goal of being the Biostatistics' leaders of delivery and execution, in a way that optimizes, expedites and delivers to the highest quality. In addition to the group's activities supporting GSK's pipeline of drugs, key accountabilities include developing and implementing strategies for programming resourcing using both internal and external resource; driving CDISC implementation for the reporting of clinical trials; and identifying and implementing IT solutions to offer further benefit and efficiency for the group's activities.
The Clinical Programming team at GSK has a strong focus on innovative ways of working and we are leading the way to implement these innovations and embracing an evolution for increased data science skills; this is already resulting in the introduction of new programming languages, technology and software. Some of these initiatives include the pathway for adoption of R and Python open source coding into day to day programming tasks, exploring machine learning to drive efficiencies for clinical reporting, developing desktop visualization capabilities and we even have an annual challenge for Programmers who are rewarded for bringing new innovations into the department. But it's not just about the tech! We also encourage involvement in other initiatives too and we focus on your personal development path, building your project and leadership skills, your inter-departmental liaison and collaboration skills and we provide you with opportunities to get closer to the science and decision making.
Within the Oncology clinical programming team Study Biomarker Programmers and Principal Biomarker Programmers support, guide, or make a major contribution to the planning and execution of multiple Biomarker-related programming activities for GSK clinical trials while in close collaboration with with Statistical Bioinformaticians and Clinical Biomarker Leads . They are accountable for creating, verifying, and documenting analyses of clinical data while adhering to study protocols, analysis plans and GSK / industry standards.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:
o Creation of biomarker analysis datasets from a variety of file and formats from either internal or external labs/vendors. The candidate should be comfortable working with a diverse collection of data files in terms of the type (depending on the assays/platform used to generate the data), data format and size.
o Creation of graphs and tables related to biomarker data primarily for exploratory investigations (hypothesis generation or evaluation) with analysis requirements that may change throughout the life of the project.
o Automation of data creation, graphs, tables and certain Statistical analyses using R scripts and developing R-Shiny apps for delivering automated analysis solutions for end users.
o Act as a subject matter expert and work as a guide within own discipline to investigate new technology as directed.
o Provide technical contribution to complex tasks.
o Ensure the collection of programs/outputs and issues are adequately managed for programming activities to achieve business outcomes.
o Apply learning from previous activities to result in quicker and more efficient completion of the current task.
o Share learnings with peers and contribute to internal technical discussions/forums.
o Initiate new directions and novel strategies to achieve department goals.
• BSc or higher in mathematics, statistics, data science, computer science or related discipline.
• Clinical Programming experience, with a thorough understanding of the end to end clinical trial process.
• Recognized expertise in R, SAS programming, and script/macro code development.
• Understanding of other products such as R-Shiny, Python, JMP, SAS/GRAPH, SAS Output Delivery System.
• Project management or relevant experience.
• Knowledge of basic computer skills (MS Word, Excel, PowerPoint, Outlook).
• Excellent communication skills with a demonstrated ability to collaborate across functions.
• A solid level of understanding of the pharmaceutical regulatory and publishing processes (e.g. 21 CFR Part 11).
• Demonstrated knowledge of and experience in the application of CDISC data and standards, primarily the creation and use of ADaM datasets.
Our values and expectations are at the heart of everything we do and form an important part of our culture.
These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork.
As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
- Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk.
- Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
- Continuously looking for opportunities to learn, build skills and share learning.
- Sustaining energy and well-being.
- Building strong relationships and collaboration, honest and open conversations.
- Budgeting and cost-consciousness.
If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).
GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
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