Statistical Analyst Consultant
The following educational and previous clinical trial experience are required for this position:
- MS / PhD in Statistics or Biostatistics or any related field.
- Clinical trial experience in a biotechnology / pharmaceutical company or CRO is preferred.
- Proficient in SAS and/or R programming.
- Good oral and written communication skills.
- Experience/skills creating high-quality graphics is a plus.
This position (remote or on-site) is responsible for supporting BDM deliverables on study design, analysis and reporting under supervision and guidance. Essential responsibilities include the following:
- 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.