Senior Biostatistician - REMOTE

Precision Life Sciences - Boston, MA

Senior Biostatistician

 

PRECISION LIFE SCIENCES

As a Senior Biostatistician will provide statistics input into the end-to-end process of clinical trials, including protocol development, development & review of SAPs, associated TFL shells and specifications to programmers, review of ADaM and SDTM datasets, preparation, review, and interpretation of statistical analyses.

What we are looking for:

  • Master’s or PhD in Biostatistics or related field
  • 5+ years’ experience in clinical trials, with some experience serving at a clinical study lead
  • Good knowledge of SAS programming (e.g., must be able to verify statistical output)
  • Good knowledge of research methodology and statistical approaches to analyzing data (e.g., time to event analyses, survival analysis)
  • Working experience in Oncology clinical trials with ADaM knowledge, SAP development, CSR writing, ad-hoc requests
  • Knowledge regarding regulatory submissions is a plus
  • Familiarity with Pharmaceutical industry and regulatory requirements for the drug development
  • Effective communicator: able to explain methodology and consequences of decisions in lay terms
  • Team player with positive attitude and good communication skills
  • Ability to be flexible when priorities change and deal with ambiguity
  • Excellent organizational and time management skills

Relevant statistical techniques needed:

  • Experience with relevant ICH guidelines
  • Experience with CDISC standards

PRECISION LIFE SCIENCES https://precision-lifesciences.com/

info@precisionlifesciences.com

 

#ADaM #SAS #BIOSTATISTICIAN #REMOTEBIOTECHJOB #REMOTEJOB #SAP #TFL #CDISC #ICH #CSRWRITING #REMOTEBIOSTATSJOB #ADHOC #CLINICALTRIALS #SENIORBIOSTATISTICIANREMOTEJOB #REMOTEBIOSTATSJOB #PHDBIOSTATS #PROTOCOLDEVELOPMENT #SAPREVIEW #TFLSHELLS #STATISTICALANALYSES #RESEARCHMETHODOLOGY #REGULATORYSUBMISSIONS #DRUGDEVELOPMENT #ICHGUIDELINES #CDISCSTANDARDS #LIFESCIENCESRECRUITER #LIFESCIENCESTAFFING #REMOTELIFESCIENCES

 

 



Posted On: Wednesday, November 23, 2022



Apply to this job

or