Description
Statistician:-Provide statistical input into protocol; CRF development in all therapeutic areas (trial design, sample size estimation, randomization, statistician methods for protocol, query check for clinical trials.
-Write detail statistical analysis plans for the clinical trials as well as for integrated summaries of efficacy and safety;
-Analyze clinical trial data producing accurate results representing the outcome of the trial;
-Validate Statistical outputs
-Co-author final integrated reports of clinical trial data reports
-Provide input into statistical SOPs and general standardization
-Participate in interacting with regulatory agencies
Requirements:
-PhD in Statistics or related field with atleast 4 years industry experience; MS in Statistics or related field with at least 7 years experience
-Experience within the therapeutic area of Oncology is preferred
-Experience with NDA submission is preferred
Experience within the theraputric area of Oncology is preferred
Experience with NDA submission is preferred
To find out more about Real please visit www.realstaffing.com