Job Description

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.



• Accountability for 5+ concurrent studies.



• Represent the Statistics function in study team meetings.

• Masters or PhD in Statistics.



• 3-5 years recent/related statistical experience within a pharmaceutical and/or medical device company, or similar organization.



• Previous experience in Clinical research.



• 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.

Job Tags

Similar Jobs