Statistician, Clinical Trial Transparency

2 weeks ago

Bengaluru, Karnataka, India GSK Full time

Site Name:
India - Karnataka - Bengaluru

Posted Date:
Jul


Key Responsibilities (No More than 10 Bullet Points): Describe the key deliverables to be achieved by the post holder and the ongoing responsibilities of the role.


  • 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.
  • 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).
  • 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).
  • Involvement in patient level data sharing, on a need basis to provide support with data anonymization of statistical output.
  • 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.
  • 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.
  • 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.
  • 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.
  • Contribute to the development of training material for the business, clinical support services and service provider(s).
  • 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.


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.

While getting ahead of disease together is about our ambition for patients and shareholders, it's 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're 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
**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.

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