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Director, Data Science - Biostatistics

CA, United States

Job description

Attention recruitment agencies: All agency inquiries are vetted through 4DMT’s internal Talent Acquisition team. No unsolicited resumes will be accepted. Agencies must be expressly engaged by the 4DMT Talent Acquisition team on any requisition. Agencies reaching out directly to hiring managers will not be tolerated and doing so may impact your ability to work with 4DMT in the future.

4DMT is a clinical-stage biotherapeutics company harnessing the power of directed evolution for targeted genetic medicines. We seek to unlock the full potential of gene therapy using our platform, Therapeutic Vector Evolution (TVE), which combines the power of directed evolution with our approximately one billion synthetic AAV capsid-derived sequences to invent evolved vectors for use in our products. We believe key features of our targeted and evolved vectors will help us create targeted product candidates with improved therapeutic profiles. These profiles will allow us to treat a broad range of large market diseases, unlike most current genetic medicines that generally focus on rare or small market diseases.  

We have built a deep portfolio of AVV-based gene therapy product candidates, with five product candidates in clinical trials: 4D-150 for the treatment of wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME), 4D-710 for the treatment of cystic fibrosis lung disease, 4D-310 for the treatment of Fabry disease cardiomyopathy, 4D-125 for the treatment of X-linked retinitis pigmentosa (XLRP), and 4D-110 for the treatment of choroideremia. In addition, we have two product candidates in preclinical studies: 4D-175 for geographic atrophy (GA) and 4D-725 for alpha-1 antitrypsin deficiency.

To-date, we have demonstrated clinical proof-of-concept for three evolved vectors in three therapeutic areas and routes of administration with five products and patient populations. We believe this validates the power of our directed evolution platform for discovering superior vectors compared to wildtype viral vectors. We have built a robust and efficient product engine with 6 open Investigational New Drug Applications (INDs) in the U.S., 1 IND in Taiwan, and 1 Clinical Trial Approval (CTA) in Australia. We believe we are positioned to create, develop, manufacture and, if approved, effectively commercialize targeted genetic medicines that could transform the lives of patients suffering from debilitating diseases.

In addition to TVE, our technology includes a robust AAV manufacturing platform and onsite manufacturing facility that allows us to rapidly produce and test research grade material and scale up to GMP clinical material. This internal capability and close collaboration between our R&D and Manufacturing teams has greatly accelerated the pace of discovery at 4DMT.

Company Differentiators: 

•    Fully integrated clinical-phase company with internal manufacturing
•    Demonstrated ability to move rapidly from idea to IND
•    Five candidate products in the clinic and two declared pre-clinical programs
•    Robust technology and IP foundation, including our TVE and manufacturing platforms
•    Initial product safety and efficacy data substantiates the value of our platforms
•    Opportunities to expand to other indications and modalities within genetic medicine

GENERAL SUMMARY:

The Director of Data Science - Biostatistics will be an experienced, hands-on biostatistician who leads the statistical activities in both strategic and operational aspects to support the clinical development of assigned programs.  Biostatistics and with the Data Management and Statistical Programming, the other two functions of the Data Science group within Clinical Development organization, provide critical support for the company’s clinical development programs in gene therapies for retina diseases and other therapeutic areas. 

RESPONSIBILITIES:

  • Provide statistical leadership, both strategic and technical, across multiple phases of drug development for assigned programs, including, but not limited to, study design/operationalization/conduct/analysis, study result interpretations, regulatory interactions, publications, and clinical development planning
  • Collaborate with relevant functional areas to reach key R&D milestones
  • Design statistical analysis plans (SAP), evaluation and interpretation of study results, as well as the preparation of statistical summary reports
  • Ensure regulatory requirements related to the specific therapeutic areas and implications are integrated into statistical methodology and analysis
  • Ensure strategic and compliant integration of CROs regarding statistical activities and responsible for the oversight of biometrics vendors for assigned projects
  • Collaborate with internal/external team members to prepare the statistical deliverables supporting various reports (e.g., IB, DSUR, CSRs, etc.)
  • Ensure high quality and effective generation of statistical deliverables
  • Design topline reports summarizing the results of milestone data analysis (e.g., interim or final analysis). Work with cross-functional team to ensure an accurate interpretation of the data
  • Provide inputs in the development and implementation of Data Science standards, process and infrastructure
  • Co-lead the design of standardization of data repository in Data Sciences group
  • Promote innovation in Data Sciences in cooperation with peers across all functions in the company
  • Keep management abreast of issues and progress on projects
  • Champion the design of an efficient, controlled and compliant communication loop to regularly address ad-hoc questions in supporting various business needs
  • Build relationships with Health Authorities and Key Opinion Leaders as needed
  • As needed, support the VP of Data Science in managing and optimizing resources for the achievement of departmental goals and business objectives
  • As needed, provide statistical support for the design and analysis of nonclinical research and development studies and quality assurance programs
  • Other responsibilities as assigned, nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time

QUALIFICATIONS:

Education:

  • M.S. or PhD in statistics, biostatistics, or closely related fields (PhD preferred)

Experience:

  • 12+ years of relevant experience (or at least 8 years for a PhD and relevant industry work) in clinical development. 
  • Experience in retina diseases and/or gene therapies
  • Deep hands-on operational experience in Biostatistics deliverables, including study design, protocol development, CRFs, clinical databases, Statistical Analysis Plans (SAP), SDTM/ADaM datasets, and CSR Tables/Figures/Listings
  • Skilled at negotiating with business partners or management and influencing senior-level leaders regarding matters of significance to the organization
  • Demonstrated contribution to the design/analysis of clinical trials and/or clinical research projects, and/or participation in the preparation of academic manuscripts or other written summaries of analysis results, thorough experience with the drug development process
  • Knowledge and experience with CDISC data standards and models
  • Familiar with clinical data management systems (e.g., Medidata Rave) and the data flow from external sources (IRT, safety, central/specialty labs, reading centers, PROs, etc.)
  • Familiar with the randomization process and the use of IRT
  • Demonstrated in-depth understanding of ICH GCP and FDA IND regulations (esp. the statistical guidelines) and experience in interacting with regulators
  • Understanding of FDA regulations in orphan diseases and/or regulations from agencies in other regions a plus
  • Experience with all clinical phases (1-4) is desirable
  • Experience with NDA/BLA filings
  • Good understanding of regulatory requirements for submission-related activities (e.g., CDISC, CDASH, eCTD) and CRT packages
  • Demonstrated ability to design and conduct statistical analyses in clinical development projects (in non-clinical research activities a plus)

Skills:

  • Innate collaborative attitude, with demonstrated ability to work effectively in a small company environment that moves at a tremendous pace
  • Strong analytical and problem-solving skills
  • Proficiency in statistical programming using SAS (and R a plus). Knowledge of other statistical and data management software packages is a plus
  • Proficient in MS Office (Work, Excel, PowerPoint)

Base salary compensation range $240,000 - $270,000

Please note: the base salary compensation range and actual salary offered to the final candidate depends on various factors: relevant work experience, skills, and years of experience

4DMT provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, genetic information, marital status, status as a covered veteran, and any other category protected under applicable federal, state, provincial and local laws.
 
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

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