Senior Documentation Lead
HCLTech
Hyderabad, Telangana, IndiaPosted about 2 months agoDiscoveredMatch locked
Full-time
Job Summary
- Create Statistical Analysis Plan
- Good understanding on ICH GCP and other pertinent regulations
- Provide inputs to Clinical Study Report
Key Responsibilities
1
- Author and/or provide input on statistical sections of clinical study documents including protocols, electronic case report forms, randomization plans, data transfer specifications, statistical analysis plans, tables, listings, and figures (TLF) shells, SDTM/ADaM specifications, clinical study reports, and other relevant documents.
- Drive TLF development and TLF reviews with programming and other relevant team members, determine analysis populations, validate key analysis results, and present final analysis results to key stakeholders
- Calculate sample sizes, as requested
- Represent the Statistics function in study team meetings
Skill Requirements
Biostatistics
Other Requirements
null
Not included in the source posting: about the role, benefits.
Skills
gcp
Who can apply
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