Job Description
Roles and Responsibilities
Prepare Sample Size calculation justification, Statistical Inputs to Protocols,
Randomization Schedule Preparation, Statistical Analysis Plan, Analysis Datasets, etc.
Provide inputs to CRF, Annotation list and Data Validation Plan
Prepare the programming specification document.
Review and provide inputs for Statistical Analysis (TLGs) and Clinical Study Report
Complete Data Validation and prepare data deviation list prior to analysis
Randomization and Unblinding of treatment arm
Timely completion of all activities with good quality
Client Communication
Generate Tables, Listings and Graphs as per Statistical Analysis Plan.
Skills and Qualifications:
Knowledge of:
Statistical techniques applicable to biomedical science
MS Office
Requirements of Good Clinical Practices
Requirements of Good Documentation Practices
Requirements of FDA 21 CFR Part 11 for Handling of Electronic Record
No Referrers Available
There are currently no referrers available for this job. You can still apply, will let you know once there is any referrer available.