Minimum Requirements: MS or PhD with 8-10 years of pharmaceutical experience
PhD in Statistics or MS with solid pharmaceutical industry experience preferred.
Submissions experience to the FDA or regulatory body
•Provide scientific statistical input to development plans and to project planning.
•Make study design recommendations and prepare sample size calculations for Outline Protocols.
•Prepare statistical section for Clinical Study Protocols.
•Generate the randomization schedules for clinical trials in accordance with the protocols and maintaining security of schedules before and during the studies.
•Provide input to the design of Case Report Forms and review Edit Check Specifications.
•Preparation of Statistical Analysis Plans.
•Interact with statistical programmers regarding programming requirements for analysis and reporting.
•Perform statistical analysis and produce derived datasets for statistical output.
•Validation/QC of other statisticians’ analysis.
•Prepare the statistical section of Topline and Final Clinical Study Reports.
•Present and discuss results with internal/external bodies as required.
•Review Clinical Protocols and Final Study Reports.
•Approve Case Report Forms.
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