Job Description

Site Name: Bengaluru Luxor North Tower Posted Date: Aug 8 2023 The Statistician, Clinical Trial Transparency is responsible for coordinating delivery of transparency documents within each therapy area (Oncology, Specialty, Vaccines), through timely and complete delivery of protocol and results summaries, full protocols, reporting and analysis plans and clinical study reports, as required by regulations and policy, for submission to key external registers e.g. ClinicalTrials.gov, EU Clinical Trial Register and the GSK Study Register. The objective is to promote consistent process for disclosure activities throughout the global organization and ensure contribution to maintenance and improvement of processes for public disclosure function according to evolving requirements. The role will report into the Operations Head, Clinical Trial Transparency. 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. 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\'s Clinical Trial Disclosure and Transparency processes. This role requires knowledge and understanding of R&D processes, statistical concepts in clinical research, as well as an understanding of the regulation. Good understanding and interpretation of trial disclosure regulations is critical for the business and it is essential that perspective from the different therapy areas is integrated in to working practices. A key aspect of the job will be to partner with, to interface and to influence key stakeholders e.g. Clinical R&D Leads, Scientific writers, Project Statisticians etc. 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. 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. 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