Job Details

Act as the core project team lead to coordinate and manage all statistical project activities
Providing statistical liaison with the client and input for protocol and CRF development.
Prepare statistical analysis plan
Perform validation and statistical quality checks on computer-generated output to verify accuracy.
Prepare or review key portions of the integrated clinical/statistical report, including sections related to data handling and statistical methodology, patient accountability, baseline comparability, and efficacy and safety results.
Attend regulatory agency meetings or respond to questions, as needed, to support the statistical analysis results of clinical trials on behalf of the sponsor.
Following departmental SOPs, OGs and relevant regulatory guidelines (e.g. ICH).

Graduate Degree in Statistics or related discipline
Min 5 years experience with drug development or related statistical analysis
Experience with the use of statistical methodology applied to clinical trials
Proficiency in SAS programming
Proven ability to meet deadlines
Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade

Reference ID - GH/PHL/Senior or Statistician III/JC//16032018//74492