To review Statistical Analysis Plan and provide inputs to the table, figure and listing shells, algorithms after comparison with data. Review as requested by Client, clinical study and analysis specifications and raise clarifications to Client or otherwise confirm that the specifications available are sufficient to perform the tasks assigned.
As required, make certain that documents and specifications are consistent and comply with company standards and/or as specified by the Client or the Client SOPs. For any discrepancy noted raise for clarification.
Create and validate, in accordance with Client Guidelines, Standard TFL Shells and SOPs; SDTM,ADAM/Analysis datasets , Data Definition Tables, Tables, Figures and Listings( to include adhoc listings if needed), from clinical study data made available through the Client Systems using SAS programs.
Perform statistical analysis tasks as requested by Client within the timeframes set out in the applicable Client SOPs or as specified by Client.
Continually check partially complete batches of data and transmit potential queries to the team lead and/or members of Clients Data Management function in the manner specified by Client.
Implement all the changes to datasets and Tables, Figures and Listings as requested by the Client.
Work collaboratively with Team Lead and Client Project programmer to resolve all data issues arising and to document outcomes.
Attend project teleconferences and Data Review Meetings with the Client as required.
Ensure documentation for the trial in accordance to GCP and Client Standard Operation Procedures (SOPs).
Perform any other related activities assigned by the supervisor and participate in task forces/initiatives.
Enhance technical skills relevant to statistics and programming.
Mentor junior programmers.
Support colleagues in non-clinical/organizational initiatives and provide inputs as required at all meetings and discussions.
Perform the following activities related to the supervisory role for the team members if applicable:
Regular 1-1 meetings.
Approve the company timesheet.
Groom identified back-up.
Send award nominations regularly.
Perform following project management activities if applicable:
Project planning and execution.
Ensure SLAs are met across projects within the group
Provide study related metrics like scorecard, status and any other metrics as requested by Client or supervisor.
Communicate with the Client regularly.
Ensure compliance with Client trainings
Timely escalation of issues if any to the process manager.
Project forecast, resource allocation and planning to ensure maximum resource utilization.