Job Description

Job Purpose:
The Statistician, Clinical Trial Transparency is responsible for the content of statistical sections of the web-based disclosure activities across projects in the respective therapy area (Oncology, Specialty, Vaccines). The role is responsible to ensure that statistical output meets requirements of external regulatory registers for disclosure of protocol and results summaries from GSK Sponsored human subject research, ensuring ethical and transparent disclosure of data in compliance with internal policy/ external regulations in collaboration with the study statistician. The role will support the implementation of new processes to meet regulatory requirements related to transparency of clinical studies and other data disclosure deliverables.

Key Responsibilities:
Responsible for the content of the statistical sections of various disclosure documents. Ensure full and accurate presentation of data (i.e. All Primary and Secondary endpoints are reported; Checks that tables responding to each endpoint, including safety are presented; Demographic table and Statistical Methods sections appropriately developed. Responsible for development of Results specification file for development of automated output for the result summaries.
2. Collaborate with Project- Statisticians on clarifying disclosure related requirements and timeliness of deliverables. Provide appropriate guidance to project statisticians to ensure all required data needed for disclosure is generated through review of the Statistical Analysis Plan and TFL (Tables, Figures & listings).
3. Ensures Quality control of the results summaries with consistency between summaries, according to the standards and in alignment with the study report content (including Full CSR versus results summary if needed).
4. Involvement in patient level data sharing, on a need basis to provide support with data anonymization of statistical output.
5. Partners with clinical study team members to ensure disclosure requirements are addressed early during the process of protocol development. Reviews protocol/ concept protocol as appropriate, for compatibility with requirements of external registers.
6. Support consistent process for trial disclosure activities throughout the therapy area. Contribute to the development of procedural documentation including guidance documents and / or instructional documents. Support maintenance and improvement of processes for disclosure function according to evolving requirements.
7. Update Disclosure systems for disclosure activities planning, tracking and delivery. Ensures archival of final records in applicable systems for the posting of the documents on the required registries.
8. Support risk management framework implementation, including risk identification, assessment and prioritization and the definition of mitigation plans. Support risk mitigation for identified business transparency risks and manage the implications of these risks on disclosure documents.
9. Contribute to the development of training material for the business, clinical support services and service provider(s).
10. Maintain awareness of changes in the disclosure, transparency and data sharing landscape, including new legal, regulatory requirements and industry trends and translate into GSK\xe2\x80\x99s Clinical Trial Disclosure and Transparency processes.

Experience Required:
Knowledge and understanding of R&D environment, and applicable disclosure requirements.
o Demonstrated knowledge and understanding of statistical concepts (e.g. primary endpoints, confirmatory analysis, mean, confidence interval, p-value) in clinical research.
o Good understanding of how to analyse and interpret clinical results.
o Proven sense of urgency.
o Excellent English language written and verbal communication skills in addition to proven negotiation skills.
o Ability to resolve problems with use of knowledge, information and networks in a flexible way and to be successful in a matrix environment.
o Self-motivated with the ability to work independently, to develop credibility with colleagues.
o Act as a role model in line with GSK core values and behaviours.
o Comfortable to evolve in changing and challenging environment.

Education
University Scientific Degree
Master or equivalent professional experience

GSK is a global biopharma company with a special purpose \xe2\x80\x93 to unite science, technology and talent to get ahead of disease together \xe2\x80\x93 so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns \xe2\x80\x93 as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it\xe2\x80\x99s also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We\xe2\x80\x99re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK\'s commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

It has come to our attention that the names of GlaxoSmithKline or GSK or our group companies are being used in connection with bogus job advertisements or through unsolicited emails asking candidates to make some payments for recruitment opportunities and interview. Please be advised that such advertisements and emails are not connected with the GlaxoSmithKline group in any way.

GlaxoSmithKline does not charge any fee whatsoever for recruitment process. Please do not make payments to any individuals / entities in connection with recruitment with any GlaxoSmithKline (or GSK) group company at any worldwide location. Even if they claim that the money is refundable.

If you come across unsolicited email from email addresses not ending in gsk.com or job advertisements which state that you should contact an email address that does not end in \xe2\x80\x9cgsk.com\xe2\x80\x9d, you should disregard the same and inform us by emailing askus@gsk.com, so that we can confirm to you if the job is genuine.

GlaxoSmithKline