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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 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 a 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, driving 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, acting 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. Provide statistical input to the design, analysis, reporting and interpretation of clinical studies.
6. Provide statistical contributions and strategic input to clinical development plans.
7. Provide leadership on regulatory strategy.
8. Build and maintain effective strategic working relationships with internal and external partners to deliver on business needs.
9. Interact effectively with key stakeholders and governance boards.
Basic Qualifications:
1. MSc or PhD in a Statistical discipline with 10+ years of experience in biotech or pharmaceutical industry.
2. Minimum three years of experience in line management of a team of statisticians including objective setting and performance reviews.
3. Experience with innovation and applying cutting-edge approaches in drug or vaccine development.
Preferred Qualifications:
1. Proven interpersonal and communication skills including experience maintaining strong working relationships.
2. Experience explaining novel and standard methods to scientific and clinical senior stakeholders.
3. Proven experience influencing across functions and levels of an organization.
4. Strong time-management skills; able to effectively organize and manage a variety of tasks across different projects.
5. 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).
6. Demonstrated ability to lead or make major contributions to department, organizational and/or industry-wide initiatives, through effective communication and influence.
7. Expertise in a range of statistical methodologies with application to real problems.
8. Examples of applying innovative statistical thinking.
9. Experience with Bayesian methods.
10. Experience across a wide range of therapeutic areas.
11. Self-motivated and independent worker.
12. Experience of working with and coordinating the work of CROs.
13. Experience working on regulatory submissions.
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