Senior Biostatistician

How you will make an impact:

• Develop Statistical Analysis Plans (SAPs) and lead the execution effort for assigned studies.
• Develop statistical programs as necessary to ensure the accuracy of the planned and completed analyses.
• Review protocols and contribute to statistical analysis sections, and generate study randomization schemes when appropriate.
• Author results sections of clinical study reports and provide statistical input for PMA submissions and responses to regulatory questions.
• Provide independent validation of statistical content in study documents including randomization schemes, reports, briefing documents, patient brochures, publications, and other content delivered to external entities.
• Interpret statistical results and clearly communicate findings, assumptions, and limitations to clinical, medical, regulatory, and other cross-functional stakeholders.
• Keep abreast of new developments in statistics, clinical research, regulatory guidance and emerging statistical methodologies through literature review and attendance at workshops and professional meetings.
• Represent Biostatistics on study teams and work with management and other team members regarding study status and timeline updates.
• Independently manage statistical deliverables, priorities, and timelines for assigned studies, and proactively communicate study status, risks, and issues.
• Participate in the developing case report forms and clinical database and data support data cleaning activities to ensure high-quality data collection.

What you'll need (Required):

• Ph.D. or equivalent in Statistics, Biostatistics, or related field, internship, senior projects, or thesis in Statistics, Biostatistics or related field.
• Master's Degree or equivalent in Statistics, Biostatistics or related field, 2 years previous analytical experience in clinical trials.

What else we look for (Preferred):

• Ph.D. in Epidemiology or related field, with relevant research, internships, thesis or other applied experience.
• Master's degree in Epidemiology or related field with at least 2 years of analytical experience, preferably in clinical trials.
• Must have solid knowledge of applied statistics and regulatory requirements, as well as effective communication and collaboration skills.
• Demonstrated knowledge and experience with survival and time-to-event analysis methods
• Strong written and verbal communication skills, including the ability to explain statistical concepts and results to both technical and non-technical stakeholders.
• Ability to work independently, take ownership of statistical deliverables, and collaborate effectively within cross-functional teams.
• Sound understanding of regulatory guidelines (e.g., GCP, FDA) as they apply to pharmaceutical and medical device research settings.
• Experience with real-world data (RWD) or real-world evidence (RWE).
• Knowledge or applied experience in Bayesian statistical methods.
• Knowledge or applied experience in causal inference methods.
• Experience with machine learning, data science, or other emerging quantitative methods.