Statistician, Clinical Trial Transparency
Company Name:-
GSK
Job Location:-
Bengaluru, Karnataka
Job Summary:-
Site Name: India – Karnataka – BengaluruPosted Date: May 12 2021
Are you looking for an opportunity to support process improvement initiatives and shares best practices related to Clinical studies and projects? If so, this is the role for you.
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 Director, 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.
This role will provide YOU the opportunity to lead key activities to progress YOUR career.
These responsibilities include some of the following:
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
FOR MORE DETAILS CLICK BELOW LINK
Now retrieving an image set.
