A global Pharmaceutical company that supports more patients through every point of their journey, with a broad set of solutions that empowers healthcare professionals to deliver smarter, more personalized care. Together, we are transforming healthcare with bold innovations that will help us realize our shared promise to improve care for all.
This role requires employees to be fully vaccinated against COVID-19 as a condition of employment, subject to a valid medical or religious accommodation.
Must have CDISC experience, a critical thinker a quick learner, good communicator and collaborative in nature.
SDTM AdAM experience is a must
Masters/PhD is a requirement, no BS.
Open to academic studies experience.
MUST be local. Not considering fully remote
Device experience is preferred but not necessary
What you will be doing at Company
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
What you will bring to Company
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