- 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
- 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.
- 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)
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Director, Biostatistics - Cambridge, United States - Editas Medicine
Description
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:
Knowledge, Skills & Capabilities:
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.
