Documentation Manager

Job Summary

• Create Statistical Analysis Plan

• Good understanding on ICH GCP and other pertinent regulations

• Provide inputs to Clinical Study Report

Key Responsibilities

• 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

• Education: Minimum of a Master's degree in Statistics, Biostatistics, Mathematics, or a related discipline.

• 5+ years of experience in similar role in the pharmaceutical or clinical research industry.

• Technical Skills: Proficiency in programming and data processing (SAS, R, SPSS, Python).

• Domain Knowledge: Understanding of clinical research, epidemiology, and biological data standards

Other Requirements

• Create Statistical Analysis Plan

• Good understanding on ICH GCP and other pertinent regulations

• Provide inputs to Clinical Study Report