Director, Biostatistics

At Editas, we’re driven by a collective purpose, to bring transformative and life changing therapies to people living with serious diseases with the greatest unmet needs. This fuels our drive to excel in scientific innovation, allowing us to harness the power and potential of CRISPR/Cas9 and CRISPR/Cpf1 (Cas12a) gene editing.
We believe our people are at the core of everything we do, and we’re committed to cultivating a culture where every individual feels valued and included. To do this, we strive to integrate belonging, inclusivity, diversity, and equity into every aspect of our organization.
Together, we are leading the way towards a healthier and more equitable future.
Key Responsibilities & Accountabilities:
Leads statistical activities for clinical development programs and provides statistical expertise in the assigned projects
Serves as a project biostatistician and ensures that the study designs are scientifically sound, and the efficacy and safety information meets regulatory requirements
Participates in protocol development and prepares statistical sections in the protocol, Statistical Analysis Plan, and Mock Tables, Listings, and Figures
Guides the project teams in using the most efficient or innovative study design by considering the regulatory agencies’ requirements for the country and regions the compound will be submitted, and help to maximize the success of the drug product
Ensures consistency in data collections, derived data definitions, analysis dataset structure, statistical analyses, and result interpretations throughout the drug development
Provides input to the entire clinical development plan to ensure that the overall strategy can deliver the pre-specified target product profile (TPP) and that proposed studies have appropriate clinical trial designs
Researches statistical methodologies for rare disease and addresses specific statistical issues in the design of clinical studies for Phase 1 through Phase 4
Guides CRO biostatistician on assigned projects to ensure consistency in derived data definitions, analysis dataset structure, analysis methodologies, and accuracy of analysis results
Ensures timely delivery of high quality deliverables
Authors documents and responses submitted to health authorities globally
Works collaboratively with other functions within Editas to meet shared objectives
Requirements
Knowledge, Skills & Capabilities:
Knowledge of ICH/EMA/FDA guidelines
Ability to innovate creatively in a clinical study design setting
Ability to effectively collaborate and influence other functions
Experience working with Statistical Programming and Data Management functions
Demonstrated ability to serve effectively as a team leader
Experience in regulatory interactions and submissions
Comprehensive knowledge of statistical methods and applications in study design and analysis
Programming skills in SAS (required) and R (preferred)
Experience in implementation of CDISC, SDTM, and ADaM datasets
Knowledge of statistical software package such as nQuery, EAST, etc.
Education & Relevant Work Experience:
MS or PhD in statistics, biostatistics, other related field with high statistical content
A minimum of five years, if PhD, of relevant experience in the pharmaceutical or biotechnology industry; a minimum of eight years, if MS (for Associate Director)
A minimum of seven years, if PhD, of relevant experience in the pharmaceutical or biotechnology industry; a minimum of ten years, if MS (for Director)
Benefits
Benefits Summary:
Editas provides a comprehensive array of benefits to all employees, including a Blue Cross Blue Shield PPO Medical Plan, a company-funded Health Savings Account, Dental and Vision Insurance, Life and Disability Insurance, Dependent Care Account, Tuition Reimbursement, 401(k) plan with company match, Employee Stock Purchase Plan, Employee Assistance Plan, Wellness Programs, and a flexible Paid Time Off policy.
If you are a results-focused and collaborative professional with a passion for advancing transformative therapies, we invite you to apply. Join us at the forefront of genetic innovation and be a key contributor to Editas Medicine's mission of redefining healthcare through cutting-edge genetic technologies.
Fostering Belonging. Fueling Innovation. Transforming Lives.