Biostatistician IV
211 Mount Airy Rd Basking Ridge, NJ 07920 US
Job Description
Target Pay Rate: 80-100/hr **salary will be commensurate with experience
Job Description:
Position entails independently designing and conducting ad hoc analyses utilizing documents, datasets and reports from previous oncology studies with minimal supervision by the lead statistician. Experience on executing post hoc analysis and integrated summaries for efficacy and safety analyses is crucial. This position contributes to specific aspects of ad hoc explorations and publications and also contributes to documents submitted to Health Authorities globally. This position also guides contract research organization (CRO) programmers and statisticians in preparing analysis files and performing statistical analyses. This position interacts with internal statisticians and internal and CRO programmers. Statistical activities include the development of SAP, shells and analysis specification files, statistical analysis accuracy validation, results interpretation and write up review. Offers recommendation to study team on all aspects of statistical activities; collaborates closely with data manager.
Skills:
- Strong knowledge of statistical methodologies, current drug development trends, and regulatory environments.
- Significant knowledge of pharmacology, clinical research, and medical terminology and use it for study design and results interpretation. Able to identify and investigate issues and causes independently and formulate potential solutions
- Able to prioritize multiple tasks, and develop instructions in completing the deliverables with high quality according to timelines, and provide recommendations to improve process
- Compliant with internal and external compliance practice to ensure integrity of work and suggest innovative approaches to improve compliances and processes
- Excellent programming skills in SAS and/or R
- Excellent oral and written communication skills.
- Working knowledge of clinical trial methodologies
Qualifications:
- MS or PhD in statistics or biostatistics with at least 5years of pharmaceutical experience;
- 2-3 years of Oncology experience, preferably from Phases 2 to Phase IV.
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