Job Description

Target Pay Rate: 80-100/hr **salary will be commensurate with experience

Responsibilities:

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 may also contribute to documents submitted to Health Authorities globally. This position also guides contract research organization (CRO) and internal programmers and statisticians in preparing analysis files and performing statistical analyses. This position interacts with internal statisticians as well as 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. This position will also review publications (manuscripts, abstracts, presentations, etc.) and may occasionally help with reviews of post market study protocols and SAPs.

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
• Strong knowledge and understanding of statistical aspects of scientific communications and publications
• 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 5 years of pharmaceutical experience;

2-3 years of Oncology experience, preferably from Phases 2 to Phase IV

**CO/NY candidates may not be considered

Job Tags

Remote job, Contract work,

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