Frequency Therapeutics is a leader in the development of medicines designed to activate progenitor cells within the body to treat degenerative diseases. The Company’s progenitor cell activation (PCA) approach stimulates progenitor cells to create functional tissue with the aim of developing disease modifying therapies. The Company’s lead product candidate, FX-322, is designed to regenerate auditory hair cells to restore hearing function. FX-322 is being evaluated in multiple ongoing clinical studies in patients with sensorineural hearing loss. The Company also is evaluating additional diseases where its PCA approach could create functional tissue, including in a pre-clinical program in multiple sclerosis.
Reporting to the Chief Development Officer, the successful Biostatistics candidate will be the key expert for statistical input into strategic clinical development planning across different therapeutic areas and design of translational and late stage clinical trials. This person will guide the approach to data collection and data management standards and provide oversight of the external vendors/CROs executing data management and statistical analysis. The Director, Biostatistics will oversee the planning, analysis, interpretation and reporting of discovery/clinical data.
- Serves as one of the internal subject matter experts in clinical statistics and clinical data management for the Discovery and Clinical functions
- Ensures adherence to industry standards and regulatory compliance for data, coding and analyses standards as well as data pooling to ensure high quality submission documents
- Collaborates in developing internal guidelines and SOPs
- Provides training to department staff on statistical concepts, methods, and techniques
- Participates in clinical study and development plan design and use state of the art statistical applications in clinical research and statistical study design
- Participates in selection and provides oversight of the vendors/CROs for statistical and data management work packages
- Drives generation and review of statistical analysis plans, compiling of tables, charts and reports
- Communicates with vendors/CROs partners regarding statistical analysis issues
- Reviews Data Management Guidelines provided by the vendors/CROs and assess accuracy and completeness
- Reviews case report forms (CRFs) design as indicated by the protocol and amendments
- Reviews data management plans, data transfer plans, and data verification plans as indicated by the protocol/protocol amendments
- Provides oversight in data processing for accurate relocation, formatting, generating and transmitting required data
- Analyses and interpretation of data for clinical trials
- Oversees writing of statistical sections of study reports
- Interprets statistical and clinical findings, and ensures that regulatory submissions, reports, and manuscripts accurately reflect the data collected
- Considers and evaluates alternative analysis methodology and data presentation
- Provides guidance for data handling including data pooling
- Interfaces with the Data Science group to define data format standards for data exchange
- Enable and participate in biomarker identification, validation and data mining
- PhD in Biostatistics, Mathematics or a related field
- 5-10 years of experience in the pharmaceutical or biotech industries
- Strong methodological technical and analytical expertise, with leadership experience in both early and late development contributing to governance milestones, strategy, health authority interactions, protocols and submissions
- Proven track record of effective leadership experience including managing reports, teams, taskforces or initiatives
- Proven knowledge and expertise in statistics, statistical programming and data management, and its applications to clinical trials
- Knowledge of FDA, EMA, ICH guidelines and regulations related to clinical trials, statistics and data handling
- Prior registration and IND/NDA/BLA experience
- Sound knowledge of clinical database management, statistical programming languages (including R and SAS), software.
- Excellent communication and presentation skills; a team player, with ability to work successfully across functions
- Experience with translational data analysis, managing biostatistics, statistical programming and data management preferred
- Experience with outsourcing biostatistics activities, and in overseeing services provided by CROs and contractors preferred.
Working at Frequency
At Frequency Therapeutics, we believe that we have the best chance to achieve our mission by creating an environment where our collective problem-solving and leadership skills are put to work, so collaboratively, we can solve some of the most complex challenges in medicine. We are focused on developing new treatments to potentially help millions of patients with novel therapeutics. This requires both a willingness to be audacious in our pursuits and relentless in our focus and commitment to research and patients. We look for individuals who are both highly skilled and self-aware, who are willing to challenge leadership and their colleagues, are entrepreneurial by nature and who are undeterred by uncertainty.
Please visit www.frequencytx.comfor more information.
We offer a competitive compensation and benefit package. For consideration, please submit CV and cover letter.