Biostatistician

Description:

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

Accountability for 5+ concurrent studies

Represent the Statistics function in study team meetings

Qualifications
 

• Masters or PhD in Statistics
• 3-5 years recent/related statistical experience within a pharmaceutical and/or medical device company, or similar organization
• Experience with different clinical phases
• Knowledge of clinical trial methodology and study design
• Study-level statistical expertise
• Proficiency in SAS and knowledge of CDISC standards
• Strong working knowledge of statistical data analysis and data management principles