Senior Biostatistician

Clinical Research and Regulatory Support

Provide statistical leadership for the design, analysis, and interpretation of clinical studies.
Develop statistical analysis plans (SAPs) for clinical investigations.
Perform statistical analyses of clinical study data and generate tables, listings, and figures.
Collaborate with clinical scientists, medical affairs, and regulatory teams in preparing clinical study reports and regulatory submissions.
Support responses to statistical questions from regulatory authorities including the FDA and other global regulators.
Provide input on study design including sample size calculations, randomization strategies, and endpoint selection.

Cross-Functional Statistical Consulting

Serve as a statistical consultant to product development, process development, quality, and operations teams.
Support engineering teams in the application of statistical techniques such as:
Design of Experiments (DOE)
Test method validation
Process capability analysis
Reliability and life data analysis
Measurement system analysis
Assist teams in developing statistically sound experimental designs and interpreting results.

Data Analysis and Communication

Analyze complex datasets and clearly communicate statistical findings to both technical and non-technical audiences.
Prepare statistical reports and presentations for internal stakeholders and regulatory submissions.