
Biostatistician
1 week ago
Role & responsibilities
- Responsible for preparation of PK and Statistical Analysis and Statistical reports (BA/BE and Phase 1) for various regulatory submissions.
- Provide statistical input and sample size calculations during protocol design
- Provide statistical/programming inputs for CRF design and review
- Generate randomization lists
- Prepare statistical analysis plans
- Perform blinded statistical review to check for data discrepancies
- Generate statistical analysis data sets
- Develop programming requirements documents for SAS programmers
- Perform data analysis and prepare statistical reports
- Generate data listings, tables and graphs
- Develop programs for quality control of analysis programs
- Provide Stat training to SAS programmers and knowledge sharing to statisticians
- Prepare integrated summaries of efficacy & safety and answer regulatory queries
- Understand and comply with all SOPs
- Preparation of appendices in eCTD format.
- Responsible to respond the sponsor/ regulatory queries
Preferred candidate profile
The candidate should have minimum 5+yrs experience in BA/BE and Phase-1 studies.
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