The Senior Biostatisticianwill support clinical studies by applying statistical expertise throughout the study lifecycle, including developing and executing Statistical Analysis Plans (SAPs), performing and validating statistical analyses and programming, contributing to protocols and randomization, and supporting clinical study reports, publications, submissions, exploratory analysis for clinical and business objectives.
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.
Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.
For California, the base pay range for this position is $119,000 - $168,000 (highly experienced).
The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.
