w
|
Clinical development plan strategy
|
w
|
Study design, endpoints selection, and analysis strategy
|
w
|
Develop protocol statistic methodology section
|
w
|
Review/write CSR statistical methods and results sections
|
w
|
Represent client in interaction with FDA
|
w
|
Study sample size and power assessment
|
w
|
Review literature and historical data
|
w
|
Design, review, and implement statistical analysis plan, including interim analysis plan
|
w
|
Manage and mentor internal junior staff
|
w
|
Evaluate and manage CROs for data management and statistics activities
|
w
|
Pharmacokinetics analysis
|
w
|
Publication support
|
w
|
Data mining
|
w
|
Experimental design and data analysis for CMC
|