Biostatistician - Preclinical Research and Development
18 hours ago
About the Role:
AmplifyBio is seeking a Biostatistician to join our team in preclinical research and development. As a Biostatistician, you will develop methodologies and analyze data to support our research and development efforts.
Key Responsibilities:
- Develop statistical methods for data analysis and ensure accuracy and reproducibility of data sets and analyses.
- Collect and collate internal data from various departments in support of nonclinical studies.
- Consolidate numerical data into databases for use by collaborating partners across the organization and external clients.
- Use statistical software to perform data analyses in support of nonclinical research studies.
- Apply advanced statistical methods, simulation models, and appropriate statistical programming to analyze complex data sets.
- 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, comply with regulatory requirements, including formatting for IND filing with the FDA.
- Provide guidance on sample size determination and experimental design.
- Mentor peers about statistical methodology and provide appropriate training to less experienced staff.
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.
About AmplifyBio:
AmplifyBio is a leading contract research organization with a comprehensive range of services that span from being an outsourcing partner for discovery stage R&D work, a preclinical CRO performing safety efficacy and toxicology studies for small molecules and advanced therapies alike, and, most recently, an expansion into manufacturing services for cell, gene, and mRNA-based therapeutics.
At AmplifyBio, we're committed to growing and empowering an inclusive community within our company and industry. This is why we hire and cultivate diverse teams of the best and brightest from all backgrounds, experiences, and perspectives across our organization.
AmplifyBio is an equal opportunity employer, and we value diversity at our company. We don't discriminate on the basis of race, color, citizenship status, national origin, ancestry, gender (including gender expression and gender identity), sexual orientation, age, weight, religion, creed, physical or mental disability, marital status, veteran status, political affiliation, or any other factor protected by federal, state, or local law.
Why You Will Love Working Here:
We take the health and happiness of our employees seriously and consistently evaluate new ways to Amp up our benefits to provide an amazing place to work. From a wellness program (did we mention we have an onsite gym with state-of-the-art equipment and ping pong table?), to financial planning and legal assistance, we make sure to take care of our own.
- Health, Dental, and Vision insurance that starts on your first day at AmplifyBio
- Competitive Compensation Package
- We take work-life balance seriously and we back it up with a FLEXIBLE PTO policy
- 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
- An Opportunity to Change the World
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