Manager - Clinical Programming
- Collegeville, PA
Site Name: UK - Hertfordshire - Stevenage, UK - London - Brentford, USA - Massachusetts - Waltham, USA - Pennsylvania - Upper Providence
Posted Date: Oct 28 2019
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 commercialisation 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 optimises, 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 visualisation 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 clinical programming team the Manager of Programming leads the planning, prioritisation and execution of multiple programming activities for GSK clinical trials, including approval of plans, accountable for creating, verifying, and documenting analyses of clinical data while adhering to study protocols, analysis plans and GSK / industry standards.
- Internally and/or externally recognised as a technical expert in their area of specialism and can apply this expertise effectively
- Acts as an expert representing department or programming function on departmental initiatives providing input and influencing groups outside of own discipline.
- Strong all-round technical competency in key areas of project delivery.
- Negotiates strategy and issues at internal regulatory meetings.
- Effectively explains concepts at all levels in the organisation, including senior managers/stakeholders.
- Defines, develops and embeds standards / best practices within a function in accordance with internal and industry standards.
- Represents programming at external discussions of technical concepts and use of standards, to advance technical capability across the Industry.
If you require a reasonable adjustment to the application / selection process to enable you to demonstrate your ability to perform the job requirements please contact (+44) 0808 234 4391. This will help us to understand any modifications we may need to make to support you throughout our selection process.
When applying for this role, please use the 'cover letter' of the on-line application to describe how you meet the aptitudes for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.
Thank you for your interest in this opportunity.
- Bachelors / Masters/PhD Degree or equivalent with extensive (and in-depth) practical experience or proven experience at the expert level.
- Experience in line management of staff.
- Experience in leading teams and business improvement efforts with positive results.
- 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.
- Demonstrated ability to influence management, stakeholders, and staff to adapt to positive change.
- Broad understanding of external landscape with respect to role and its related functions (e.g., Clinical Data Interchange Standards Consortium (CDISC), cancer Biomedical Informatics Grid (caBIG), outsourcing strategies).
- Experience in applying creative thinking/business analysis skills in order to improve or solve business problems.
- Demonstrated effectiveness in building, managing and leveraging networks/client relationships internally.
- Ability to manage conflicting demands and priorities and to negotiate successfully.
- Project management or relevant experience
- Demonstrated ability to manage the outsourcing or externalization of statistical programming work in the clinical trials setting (e.g. working with CROs, academic institutions)
At GSK, our mission is to improve the quality of human life by enabling people to do more, feel better and live longer. Our three world-leading businesses research and deliver innovative medicines, vaccines and consumer healthcare products. We need a talented and motivated workforce to deliver against our strategy. To achieve this, we strive to attract the best people and to create an environment that empowers and inspires.
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