GSK site preferred locations: Rockville, MD, Wavre, Belgium, Stevenage, UK, GSK House. On-site presence of 2-3 days per week average is required. Additional flexible arrangements considered on case by case basis.
The primary purpose of this job is to seek for talented Director-level people who can provide expert statistical and strategic support to asset development programs in GSK Vaccines pipeline. This job requires someone who is technically excellent, continuously proactive, and comfortable with autonomy, innovation, empowerment, and accountability; The successful candidate will drive statistical excellence and strategic influence on clinical development plans for the project(s) in GSK vaccines as well as strong passion for mentoring and developing staff.
Key Responsibilities include, but are not limited to:
1. Lead the statistical input to the project development team, leading the driving of innovation and ensuring commitment to quality standards, processes and efficient delivery
2. Contribute to strategic planning and quantitative decision making
3. Foster and encourage a culture of innovation, and act as a role model to others in actively owning and driving the use of innovative methods where appropriate.
4. Provide statistical leadership within the clinical statistics department and R&D organization
5. Providing statistical input to the design, analysis, reporting and interpretation of clinical studies
6. Providing statistical contributions and strategic input to clinical development plans
7. Providing leadership on regulatory strategy
8. Building and maintaining effective strategic working relationships with internal and external partners to deliver on business needs
9. Interacting effectively with key stakeholders and governance boards
Basic Qualifications:
10. MSc or PhD in a Statistical discipline with 10+ years of experience in biotech or pharmaceutical industry
11. Minimum three years of experience in line management of a team of statisticians including objective setting and performance reviews
12. Experience with innovation and applying cutting-edge approaches in drug or vaccine development
Preferred Qualifications:
13. Proven interpersonal and communication skills including:
14. Experience maintaining strong working relationships
15. Experience explaining novel and standard methods to scientific and clinical senior stakeholders.
16. Proven experience influencing across functions and levels of an organization
17. Strong time-management skills; able to effectively organize and manage a variety of tasks across different projects.
18. Track record of strong statistical contributions and accomplishments in clinical development, with a broad knowledge of all phases of drug development (pre-clinical; Phase I-IV).
19. Demonstrated ability to lead or make major contributions to department, organizational and/or industry-wide initiatives, through effective communication and influence.
20. Expertise in a range of statistical methodologies with application to real problems
21. Examples of applying innovative statistical thinking
22. Experience with Bayesian methods
23. Experience across a wide range of therapeutic areas.
24. Self-motivated and independent worker
25. Experience of working with and coordinating the work of CROs.
26. Experience working on regulatory submissions
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GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).
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