axogen · 2 months ago
Biostatistician – Clinical Trials (Drug/Biologic)
Tampa, Florida, United States
Full-time
Onsite
Mid, Senior Level
$122K/yr - $153K/yr
5+ years expAxogen is dedicated to restoring health and improving quality of life through innovative solutions in peripheral nerve function. The Biostatistician will design and conduct clinical research studies, develop statistical analysis plans, and perform complex statistical analyses to support the company's mission.
BiotechnologyMedicalMedical Device
Responsibilities
Lead efforts in resolving day to day work related issues and problems, securing quality, improving efficiency and productivity of statistical and programming operations
Apply project management skills, statistical and programming techniques, and achieve quality and on time delivery of deliverables
Coordinate activities with project/program overall management personnel to achieve program objectives
Under supervision may represent the company to interact with regulatory agencies regarding matters relating to the statistical areas of the responsible projects/programs
Provide strong statistical expertise for design, analysis and reporting of clinical trials and research projects
Write statistical sections of study protocols, perform sample size calculation, develop randomization specifications, and generate randomization codes
Write Statistical Analysis Plans (SAPs) and properly address quality control (QC) review comments
Create and maintain Statistical and Programming QC and QA Plans for assigned projects or programs
Provide input to unblinded data management plan when required
Participate or lead research and development of statistical methodologies and processes
Lead efforts in planning, researching and designing statistical methods and approaches in solving complex trial data analysis and operational issues
Develop and/or review ADaM and/or SDTM dataset specifications. Lead efforts in resolving complex data derivation and data handling issues
Perform statistical programming to either build analysis datasets and generate statistical tables, listings and graphs (TLGs) or perform QC validation of these datasets and TLGs
Lead statistical dry runs and final run by actively participating or contributing to project and resources management, addressing statistical and programming questions and interacting with data management to follow up and resolve data issues
Review and provide input to Data Standards
Review comments to ensure quality of documents
Perform QC programmatic checks on core study results as well as overall quality/consistency review of statistical TLGs
Perform complex statistical modeling and analyses, implement new statistical analysis methods and strategies
Perform statistical analysis as per SAP, and address peer/QC review comments and findings
Perform statistical validation of core results, address additional QC validation comments and findings on the core results
Plan and conduct or contribute to the trial results reporting
Contribute to the contents describing any deviation from the planned analysis and deviation from study conduct for the Clinical Study Report (CSR). Review CSR to ensure accuracy, completeness and appropriateness of the interpretation of the statistical results
Write statistical report or statistical sections of the CSR, or perform peer review of the contents
Perform statistical analyses for publications, including but not limited to abstracts, manuscripts, presentations and posters
Provide statistical input to Case Report Forms (CRF) design and database/variable structure
Provide statistical input to non-CRF data collection and acquisition methods and approaches
Review Data Management Plan sections relating to critical data collection and cleaning. Provide statistical input to Data Validation Specification
Specify and/or program database quality acceptance checks, assess and report data quality issues, and follow through until resolution
Perform ongoing assessment and communication of data quality issues, including protocol deviations
Assist data management and trial management team in preparing for database lock
Perform other duties as directed by the Supervisor
Qualification
Required
A Ph.D. degree or equivalent in statistical science, mathematical analysis or related field plus 5 years' relevant experience or a master's degree plus 8 years' relevant experience with demonstrated ability and sustained performance at the Ph.D. level
Minimum 5 years of experience working in the biologic/biotechnology, pharmaceutical, and/or medical device industry
Demonstrated success in delivering on goals and being part of fast-moving, collaborative team
Broad regulatory understanding of functions and processes involved in pharmaceutical, biologic, and/or medical device product development
Must demonstrate strong interpersonal, written, and oral communication skills across various levels of management and demonstrate the ability to manage differences and needs between multiple stakeholders
Benefits
Health
Dental
Vision
Matching 401K
Paid Time Off
9 Paid Holidays + 3 Floating Holidays
Dependent Care Flexible Spending Accounts
Medical Flexible Spending Accounts
Tuition Reimbursement
Paid Parental Leave
Paid Caregiver Leave
Basic Life Insurance
Supplemental Life Insurance
Employee Stock Purchase Plan
Disability Insurance
Company
axogen
AxoGen is a biotech company developing treatment options for the reconstruction and repair of peripheral nerve injuries.
201-500 employees
H1B Sponsorship
axogen has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (1)
2020 (1)
Funding
Current Stage
Public CompanyTotal Funding
$131.92MKey Investors
PDL Biopharma
2017-11-15Post Ipo Equity· $41M
2015-08-28Post Ipo Equity· $17.5M
2015-02-05Post Ipo Equity· $13M
Leadership Team
Michael Dale
President and Chief Executive Officer
Marc Began
Executive Vice President, General Counsel
Recent News
2025-12-05
2025-12-05
2025-12-04
Company data provided by crunchbase