About the position
The Biostatistician at AmplifyBio plays a crucial role in developing methodologies and analyzing data to support pre-clinical research and development. This position focuses on ensuring the accuracy and reproducibility of data analyses, providing guidance on statistical methods, and mentoring peers in statistical methodology. The Biostatistician will work closely with various departments and external clients to consolidate and interpret data, ensuring compliance with regulatory requirements.
Responsibilities
- Develop appropriate statistical methods for data analysis and ensure the accuracy and reproducibility of data sets and analyses.
- Collect and collate internal data from various departments in support of nonclinical studies and internal initiatives.
- Consolidate numerical data into databases for use by collaborating partners and external clients.
- Use statistical software to perform data analyses in support of nonclinical research studies.
- Apply advanced statistical methods, simulation models, and programming to analyze complex data sets, ensuring accuracy and data integrity.
- Provide concise data interpretation in written reports and verbal communications with internal partners and external clients.
- Outline best practices for data analysis for nonclinical studies and comply with regulatory requirements.
- Provide guidance on sample size determination and experimental design.
- Mentor peers about statistical methodology and provide training to less experienced staff.
- Perform other duties as assigned.
Requirements
- MS or Ph.D. in Statistics or Biostatistics with on-the-job experience as a Biostatistician.
- At least five years of experience with mainframe and/or PC databases, document processing, and statistical software such as STATA, SAS, R, and S-Plus.
- Strong oral and written communications skills, with the ability to effectively communicate internally and with clients.
- Demonstrated understanding and insight into statistics and relevant FDA regulations.
- Pharmaceutical, CRO, or related industry experience with pre-clinical data sets, including interaction with Regulatory Agencies.
Nice-to-haves
- Comfort with technology, especially databases and statistical analysis software.
- Strong understanding of statistical methods and formulas with effective analytical thinking and problem-solving abilities.
- Effective data analysis skills.
- Organizational skills and attention to detail.
- Professional presentation skills.
- Experience working with FDA.
Benefits
- Health, Dental, and Vision insurance that starts on your first day.
- Competitive Compensation Package.
- Flexible PTO policy for work-life balance.
- Generous paid parental leave.
- Wellness and Self-Care Programs.
- 401(k) match.
- Tuition Reimbursement.
- EAP/work-life support system.
- A fun work environment where everyone's voice matters!
