Senior Director/Vice President, Biometrics

Translate Bio

Senior Director/Vice President, Biometrics

Company Overview
We are a leading mRNA therapeutics company developing a new class of potentially transformative medicines to treat diseases caused by protein or gene dysfunction. Using our proprietary mRNA therapeutic platform (MRT), we create mRNA that encodes functional proteins. Our mRNA is delivered to the target cell where the cell’s own machinery recognizes it and translates it, restoring or augmenting protein function to treat or prevent disease.

At Translate Bio, we’re also passionate about our five core values: Put People First, Be Approachable, Act as One, Be Tenacious, and Be Bold. These values embody our culture and underscore our mission to bring mRNA therapeutics to all.
Job Summary
Reporting to the Chief Medical Officer, the Senior Director/Vice President, Biometrics, is responsible for the leadership, strategic planning, oversight, and execution of biometrics deliverables for early through late stage development strategy to support global registration of company products.

This individual will oversee all biometrics workstreams for clinical trials, regulatory submissions, and business development data evaluations. This individual will be an effective and engaged leader capable of working in a fast-paced environment, flexing with changes and growth in the organization. This leader will have significant expertise in the successful design and implementation of clinical trials and work collaboratively with Clinical and Development Operations functions internally and with partners to ensure rigorous collection and analysis of data across Phase 1-4 studies.

As the Senior Director/VP of Biometrics of a growing organization, this leader will have a growth mindset with experience in using innovative statistics methods including methodologies such adaptive designs, and platform trials. The VP Biometrics will partner with the research and development organization to establish strategic collaborations with external organizations to broaden internal expertise, and opportunities to apply a diversity of approaches to generate impactful patient and biomarker data.

As the portfolio grows, this role will also be accountable for bringing the biometric functions in-house and supervising the growth of the biometrics department.
Job Responsibilities
  • Provides strategic leadership and works closely with cross-functional Development organization leadership that includes Preclinical Translational Biology, Clinical Operations, Regulatory and Clinical, Quality, and Pharmacovigilance
  • Represents Biometrics function at global regulatory meetings and contributes to Translate Bio’s responses to regulatory agency questions and requests for information
  • Leads the statistical strategies for clinical development of drug candidates  from First-in_Human, through Proof-of-Concept and pivotal Phase 2/3 studies and NDA/MAA/BLA submissions.
  • Oversees and provides hands on support to ensure the statistical integrity of analysis and reporting deliverables, including guidance on statistical methodology, optimization of study designs, endpoint selection, authoring and reviewing documents (statistical sections of the protocol, clinical study reports and related documents), and oversight of timelines and study level tasks pertaining to statistical analysis and reporting.
  • Collaborates with Clinical Operations to select, oversee, contract, and manage Biostatistics vendors and contract research organizations.
  • Responsible for final data check and data integrity of all outward-facing materials (posters, manuscripts, investor-related materials)
  • Consults on methodologies for modeling large scale data (e.g., metabolomics, genetics) for Discovery and Development organization
  • Provides support for business development opportunities
  • Provides support for novel endpoints, including digital endpoints
  • Ensures alignment with broader Translate Bio strategic initiatives and business needs
Required Skills & Qualifications
  • PhD in Statistics or Biostatistics with 8+ years clinical development experience in pharmaceutical / biotech/ CRO environment with 4+ years of managing, mentoring and developing team members
  • Leadership experience building and managing relevant functions in this role (e.g Biostatistics or Data Sciences)
  • Experience managing resources and budgeting across therapeutic areas, sets priorities, and ensures consistency and adherence to standards
  • Experience supporting global regulatory submissions, interacting with the FDA and global regulatory authorities.
  • Experience programming in SAS, R, Shiny, Markdown; able to use other relevant statistical software solutions and able to direct programming, working knowledge of Git and Unix/Linux environments.
  • Strong understanding and experience with industry data standards, including CDISC compliant datasets, SDTM and ADaM data models
  • Knowledge of applicable regulatory rules and guidelines, e.g., ICH, GCP, HIPAA
  • Strong application of innovative study designs and developing milestone criteria (e.g. Go/No Go criteria)
  • Detailed knowledge of noninferiority testing, multiple imputation, meta-analysis, repeated measures, and survival analysis, adaptive designs, Bayesian methodology, trial simulation, and data modeling
  • Demonstrated success in working in a matrix environment.
  • Outstanding communication skills, including clarity in scientific/technical writing, ability to explain complex concepts to others, and willingness and ability to engage in scientific discourse at the executive level.
Translate Bio is committed to equal employment opportunity. All applicants must have authorization to work in the U.S.