Sr Biostatistics Consultant

Responsible for supporting BDM deliverables, specifically the Cardiovascular group, on study design, analysis and reporting under supervision and guidance. Essential responsibilities include the following:
The following specifications provide the job requirements for Statistical Analyst Consultant for the Biostatistics and Data Management Department (BDM). Supports design, execution and reporting of clinical trials, under the direct supervision of an experienced study statistician. Prepares mock tables/figures/listings (TFL) and works closely with the study statistician and the study statistical programmers to generate and review TFLs for clinical study reports, integrated summaries of safety (ISS), and integrated summaries of efficacy (ISE). Performs exploratory and ad hoc analyses of clinical trial data under the direction of the study statistician. Prepares TFLs to support DSUR and IB documents. Under the direction of the study statistician, coauthors statistical analysis plans and reviews data specs that support the statistical analyses. Collaborates with study team members to implement protocol deviation process. Experienced candidates will coordinate departmental deliverables for DSUR
and IB submissions, as well as assisting the lead project statistician on tracking timelines and deliverables for clinical studies.

Self-motivated biostatistician with 9+ years of experience supporting clinical trials and publications. In-depth working knowledge of the drug discovery process, and statistical analysis experience in Phase 2 & 3 protocols. Cardiovascular therapeutic area experience helpful but not necessary. Strong analytical skills with the ability to process scientific and medical data. Proficient in programming using SAS. Strengths include working with cross-functional teams, problem solving, written and oral communication, and study management.