Biostatistician

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Job description

Are you passionate about significantly improving the future of medicine? Do you believe that people are the most important asset of any company? If so, join 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.

The AmplifyBio ecosystem is comprised of three distinct business units: ADOC (South San Francisco, CA)- Amplify's Discovery, Optimization, and Characterization laboratories: ASET (West Jefferson, OH) - Amplify's Safety, Efficacy, and Toxicology Site; and the most recently opened AMEC (New Albany, OH) - Amplify's Manufacturing Enablement Center.

About ASET West Jefferson, OH: AmplifyBio's safety, efficacy, and toxicology unit (ASET) was launched as a preclinical CRO that spun out of Battelle in 2021 to address the changing needs of commercial organizations developing modern therapeutics. AmplifyBio brings decades of experience to accommodate a wide variety of GLP and non-GLP studies in all in vivo models and dose routes. Among the investments that AmplifyBio has made to empower preclinical assessments of advanced therapies is building a new state-of-the-art analytical laboratory to include molecular and immunological assays that assess critical safety and efficacy indicators for cell and gene therapies during preclinical studies.

AmplifyBio is currently seeking a Biostatistician to join our growing team!

The Biostatistician develops methodologies and analyzes data in support of pre-clinical research and development to make predictions and draw meaningful conclusions from results.

What You'll Do Here:

• Develop appropriate statistical methods for data analysis and ensure the accuracy and reproducibility of data sets and analyses of data by following relevant guiding documents and procedures.
• Collect and collate internal data from various departments in support of nonclinical studies as well as internal research and development and/or other internal initiatives.
• 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, 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, 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.
• Perform other duties as assigned.

We Would Love to Hear from You If:

• 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.

Desired But Not Required:

• 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.

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

When you join our team, you will be a part of groundbreaking work while collaborating with our clients, research scientists, study directors, lab technicians, and specialists across a variety of disciplines. The future for AmplifyBio is as great as the combination of our imaginations and actions, and we hold ourselves accountable for our choices and results. We have a bias for action, excellence, and, especially, the health and safety of our employees.

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