Job Description

GSK Oncology has a commitment to the discovery and development of new oncology therapies with the life-changing potential of helping patients with cancer.

We need exceptionally talented and committed Statisticians like you to apply your statistical skills and innovative statistical methodology to drive key contributions in the marketed product support of new medicines in the fight against cancer.  You will provide global statistical support in non-registrational data generation, secondary publications, and scientific congress support, and ISR review to support delivery of clearly differentiated medicines to our patients.  You will also collaborate with R&D, medical and commercial organizations   to deliver a diverse book of work to support market access for GSK oncology marketed products and late-stage pipeline assets. Join our team of industry leading experts in data analysis and methodologic research. Our end-to-end project support model ensures that our statisticians have the opportunity to collaborate across the entire range of drug development, from early clinical development to registration and marketed product support.

Key Responsibilities:

The responsibilities listed below outline the scope of the position. The application of these tasks may vary, based upon evolving business needs.

Providing statistical input to the design, analysis, reporting and interpretation of non-registrational studies.

Influencing clinical development plans, regulatory and commercial strategies.

Building and maintaining effective strategic working relationships with internal and external partners to meet business needs.

Identifying, developing and implementing novel statistical methodologies.

Addressing challenges in market access and reimbursement raised by regional agencies such as the Institute for Quality and Efficiency in Health Care (IQWiG) and Federal Joint Committee (G-BA) in Germany, UK National Institute for Health and Clinical Excellence (NICE), France Haute Autorité de Santé (HAS) and Australia Pharmaceutical Benefits Advisory Committee (PBAC), in collaboration with other functions

Partnering with RU statisticians to participate in the review of Investigator Sponsored trials and GSK sponsored Phase IV trials (including post marketing commitments).

Collaborating with global/regional Health Economics and Market Access Teams on identifying analysis methods and interpretation of observation data and other real-world type data (such as Patient Registries and Claims Data Bases).

Investing in developing knowledge outside of conventional statistical expertise in the clinical, regulatory and commercial environments.

Influence planning and decision-making strategy over a portfolio of assets through building and maintaining effective business relationships with medical and commercial organizations.

Formulate a data strategy to effectively leverage both internal and external data analyses to inform R&D oncology organization for potential future development opportunities

Basic Qualifications

MSc or equivalent degree in a Statistical discipline with relevant experience?in a clinical research, Pharmaceutical, CRO or Academic setting.

Track record of strong statistical contributions and accomplishments in medical affairs and market access of marketed products.

Strong Oncology experience.

Self-motivated and independent worker.

Strong time management skills; able to effectively organize and manage a variety of tasks across different projects.

Excellent interpersonal and communication skill, including:

Demonstrated ability building and maintaining strong working relationships.

Ability to explain novel and standard methods to scientific and clinical senior stakeholders.

Experience successfully influencing effectively across functions and levels of an organization.

 Preferred Qualifications

PhD Degree in a Statistical discipline

Demonstrated ability to lead or make major contributions to department, organizational and/or industry-wide initiatives, through effective communication and influence.

Capable of applying innovative statistical thinking.

Excellent interpersonal and communication skills.

Capability in building and maintaining strong working relationships?in a team setting.

Demonstrated ability to explain novel and standard methods to scientific and clinical colleagues.   o   Familiarity with the global reimbursement landscape   o   Familiarity with oncology and/or time to event endpoints o   Managing staff  o   Matrix management priorities

Strong influencing skills applied effectively across functions and levels of an organization

Experience of working with and coordinating the work of CROs.

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