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Senior Biostatistician

2 months ago

Hyderabad, India Parexel Full time

When our values align, there's no limit to what we can achieve.
 

PhD or MS in Statistics or related discipline with relevant experience of 5 - 8 years. Statistician for Phase I-IV clinical studies in different therapeutic areas. Provide statistical inputs in protocol, database design, manuscript writing and overall conduct of the study. Perform sample size calculation and generate randomization schedule as per study requirement. Write and review statistical analysis plan, statistical sections in protocol, clinical study reports for regulatory submissions and journal manuscripts. Perform all statistical activities including mock shell development, prepare/review safety and efficacy TLFs, qcing primary endpoints related datasets/outputs using double programming in SAS. Prepare and review key portion of clinical study report and academic research manuscript, including sections related to data handling and statistical methodology, patient accountability, efficacy and safety results Prepare study timelines and execute them for the timely submission of deliverables.