I am looking to change jobs to the pharmaceutical industry in the field of Biostatistics and looking for a trainer to help me train for the day to day entry level Biostatistician tasks. I am looking for an experienced Biostatistician who has worked in the industry for at least 4-5 years.
The prospective trainer should be proficient in the following-
- Collaborates with program staff on the implementation and analysis of statistical aspects of research protocols.
- Assists Senior Statistician in providing statistical consultation for clinical programs, including but not limited to randomization, sample size assessments, efficacy evaluations, and data review.
- Interfaces with clients as the project biostatistician.
- Provides input to project timelines, and ensures that project timelines for biostatistics deliverables are met for both internal and external clients.
- Ensures that project tasks are completed with acceptable quality for both internal and external clients.
- Coordinates with SAS programming staff to ensure the accurate programming of SAS clinical data extracts and data displays.
- Develops statistical analysis summary and analysis plans, including textual description of planned analysis and mock-ups of data displays.
- Reviews and provides comments on statistical summaries.
- Develops programming specifications to summarize the results of clinical trials, including analysis datasets and tables/listings/figures.
- Performs statistical analyses, including hypothesis testing and modeling.
- Provides tabular and written summaries of analyses and statistical methodology for Clinical Study Reports.
- Interacts with Medical Writers to ensure appropriateness of data inferences.
- Writes pertinent sections of a clinical study report.
Preferred if you have experience with-
-ADAMS and SDTM listings and specifications (Analysis Datasets and Standard datasets)
- Statistical Analysis plan development
- CDISC and CDASH knowledge
- BLA and NDA submissions
-NQuery software analysis
- TLF specifications reviewing
- [login to view URL] (single or double [login to view URL]) and Reviewer's Guide development
Please read the details of the posting thoroughly before replying. Automated messages will be reported. Please include the headline 'Clinical Report Form' in the message while messaging on Freelancer. Budget is negotiable depending on the skills and deliverance of the trainer.