Senior Biostatistician

Title - Biostatistician IV

Duration - 6 months

Location - Basking ridge, NJ

Shift - Remote

Job Schedule : Remote candidates are willing to work based on Eastern Standard Time (EST) or Central Standard Time (CST).

This position contributes to specific aspects of ad-hoc explorations and publications. Position entails independently designing and conducting ad-hoc analyses utilizing documents, datasets and reports from previous cardiology studies with minimal supervision by the lead statistician. Experience in executing post hoc analyses and integrated summaries for efficacy and safety analyses is crucial. This position also entails guiding internal and contract research organization (CRO) programmers and statisticians in preparing analysis files and performing statistical analyses. Statistical activities include the development of SAP, shells and analysis specification files, statistical analysis accuracy validation, results interpretation and write up review and offering recommendation to the study team on all aspects of the statistical activities.

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

Strong knowledge of statistical methodologies, current drug development trends, and regulatory environments.

Significant knowledge of pharmacology, clinical research, and medical terminology, specifically in the cardiology area, 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 specifically for cardiovascular diseases.

Remarks :

MS or PhD in statistics or biostatistics with at least 5years of pharmaceutical experience.