A high profile, global leadership opportunity within our Quantitative Sciences business has come up. The role is reporting to the Therapeutic Area (TA) Head of Clinical Programming for the Immuno-Immunology group.
GlaxoSmithKline is one of the world's leading pharmaceutical and healthcare companies, with statisticians and programmers working in Research and Development at UK and US sites. The Quantitative Sciences division includes a Clinical Programming department, sitting within the broader Clinical Statistics group, covering all phases of clinical drug development and commercialisation in a wide range of therapeutic areas. In recognition of the developing sophistication and technical requirements of the role, Clinical Programming was formed as a standalone department distinct to Clinical Statistics. 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, external, onshore and offshore 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.
Key Responsibilities include, but are not limited to:
• Oversees programming activities across multiple assets to deliver data a high-quality data analysis outputs
• Serves as the contact and advocate for the programming function in proposing, negotiating and managing delivery of programming expertise to enhance business processes.
• Broad recognition for strong all-round technical competency in key areas of programming across R&D
• Provides state-of-the-art programming knowledge / skills for process improvement initiatives or other major change initiatives.
• Leads initiatives to improve quality, efficiency or adherence to standards, including cross-functional initiatives across multiple departments
• Effectively monitors quality within area of responsibility, including both internal and outsourced activities.
• Sets strategy for developing and embedding standards across functions in accordance with internal and industry wide standards
• Drives efforts to improve quality and efficiency of programming activities in a function
• Serves as the contact and advocate for the programming function in proposing, negotiating and managing delivery of programming expertise to enhance business processes
• Impactful interactions with regulatory agencies, external experts and/or other organisations regarding strategy and delivery
• Leads, or makes major contributions to, industry-wide initiatives as part of an external working group/committee
• Ability to build credibility and presence with customers at all levels of support
• Drives efforts to improve data visibility, quality and efficiency of flow from start-up through the reporting and archiving stages of clinical studies and system development including data re-use strategies (e.g., development of Quality Metrics/ Dashboards, Spotfire, data aggregation).
• Develops, implements and actively manages strategies to mitigate GSK's risk related to loss of revenue, intellectual property and corporate reputation.
CLOSING DATE for applications: Tuesday 30th April (COB)
Please take a copy of the Job Description, as this will not be available post closure of the advert.
When applying for this role, please use the ‘cover letter’ of the online application or your CV to describe how you meet the competencies 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.
During the course of your application you will be requested to complete voluntary information which will be used in monitoring the effectiveness of our equality and diversity policies. Your information will be treated as confidential and will not be used in any part of the selection process. 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 0808 234 4391. This will help us to understand any modifications we may need to make to support you throughout our selection process.
Why You?Basic qualifications:
• Bachelors / Masters/PhD Degree or equivalent with extensive (and in-depth) practical experience or proven experience at the expert level.
• Demonstrated ability to influence management, stakeholders, and staff to adapt to positive change.
• Experience in line management of staff.
• Broad understanding of external landscape with respect to role and its related functions (e.g., Clinical Data Interchange Standards Consortium (CDISC), outsourcing strategies
• Experience in leading teams and business improvement efforts with positive results.
• Experience in applying creative thinking/business analysis skills to improve or solve business problems.
• Demonstrated effectiveness in building, managing and leveraging networks/client relationships internally
• A solid 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
• Knowledge of basic computer skills (MS Word, Excel, PowerPoint, Outlook)
• Ability to manage conflicting demands and priorities and to negotiate successfully
• Effective Project management skills 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)
• Effective written and verbal communication skills
GlaxoSmithKline is a science-led global healthcare company that researches and develops a broad range of innovative medicines and brands. We discover, make and market life-enhancing products that are used by millions of people around the world, helping them to do more, feel better and live longer. We have 3 primary areas of business in pharmaceuticals, vaccines and consumer healthcare. We have offices in more than 115 countries, major research centers in the UK, USA, Spain, Belgium and China and an extensive manufacturing network with 87 sites globally. Our three strategic priorities are to grow a diversified global business, deliver products of value, and to simplify our operating model.
You may apply for this position online by selecting the Apply now button.
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