Anna Burkhardt
Vice President, Biostatistics and Statistical Programming
Be confident that your day-to-day biometrics partners are highly qualified experts and will respect your funding and timelines by doing things right every time. Whether we’re consulting with you or delivering the entire statistical workflow, our full-service clinical data management and biostatistics capabilities prioritize data quality and integrity.
Extensive Experience Across All Phases of Product Development
Our expertise covers the data requirements of all clinical trial phases, as well as registration and observational studies. From study design to analysis planning to regulatory submissions, we make sure your data is airtight, readying your therapy for the spotlight.
Expertise Across Complex Indications
Biostatistics and statistical programming proficiency go hand-in-hand with our deep knowledge of complex indications and therapeutic areas. We deliver to the highest data standards on the most current data platforms.
High-quality data is vital for clinical and regulatory success. Our advanced biometrics solutions provide clear and reliable insights into efficacy and safety, paving the way for seamless regulatory approval.
Meet Some of Our Biometrics Experts
- 14+ years of professional experience in biostatistics and statistical programming
- Expert knowledge in a multitude of indications such as oncology, immunology, and neurology
Tina Pietropaolo
Executive Director, Data Management
- 25+ years of experience in the pharmaceutical, biotech, and CRO industries
- Expertise in various EDC Platforms including Medidata and Veeva CDMS
Adam Key
Executive Director, Statistical Programming
- 15+ years of professional experience in statistical programming
- Skilled in SDTM, ADaM, statistical analyses, SAS Programming, Good Clinical Practice (GCP), and CDISC Standards
