Associate Director, Biostatistics
About the Company
Replimune’s mission is to revolutionize cancer treatment with therapies designed to activate a powerful and durable full-body anti-tumor response, boldly transforming cancer care because patients’ lives depend on it. At Replimune, we live by our values: united, audacious, dedicated, and candid. People are at the center of everything we do, with a deep sense of purpose, a strong and evolving culture, and a competitive total rewards program. Join us as we reshape the future of cancer treatment.
Replimune Group, Inc., headquartered in Woburn, MA, was founded in 2015 to pioneer the development of a novel portfolio of oncolytic immunotherapies. Our proprietary RPx platform is based on a potent HSV-1 backbone designed to maximize immunogenic cell death and induce a systemic anti-tumor immune response. The RPx product candidates are expected to be synergistic with most established and experimental cancer treatments.
About the Role
The Associate Director, Biostatistics provides statistical support for one or more clinical trials, including statistical analysis and tracking systems to determine trial efficiency. This role interacts with the clinical development team to support protocol design, evaluates databases and statistical analysis programs, and ensures study designs are scientifically sound while meeting regulatory requirements for efficacy and safety endpoints.
This position can be based in our Woburn office or remote. Remote candidates (living beyond 65 miles of Woburn HQ) must be open to 15-25% travel to Woburn every 4-6 weeks or as business needs require.
Responsibilities
- Provide statistical support to the compound statistical leader for clinical development plans and trials.
- Provide statistical input to study protocols, develop statistical analysis plans, tables/listings/figures, and oversee database monitoring and lock activities.
- Serve as biostatistics lead for assigned clinical studies, publications, and conference presentations.
- Assist in writing relevant sections of clinical study reports and publications.
- Monitor and guide internal biometrics team and CRO project activities, including timelines, deliverables, and resources.
- Participate in pre-IND and NDA/BLA activities.
- Use SAS to perform efficacy analyses and validate important data derivations.
- Develop and implement department standards and lead process improvements.
- Perform other duties as assigned.
Requirements
- PhD or MS in Biostatistics or Statistics.
- At least three (3) years of experience for PhD or five (5) years for MS as a statistician in the pharmaceutical or biotechnology industry.
- Oncology (especially solid tumor) clinical trial experience preferred.
- Knowledge of advanced study design and up-to-date biostatistical methodologies.
- Experience with NDA/BLA eCTDs or other global regulatory submissions preferred.
- Experience as an independent statistician with responsibility for multiple studies or projects.
Skills
- Excellent interpersonal, leadership, and communication skills.
- Ability to work independently and collaboratively.
- Proficiency in statistical programming languages (including SAS).
- Knowledge of SDTM/ADaM.
Pay
The anticipated base pay range for this role is $193,500–$250,500. The exact base pay will depend on qualifications, skills, experience, and organizational needs. In addition to base pay, the selected candidate will be eligible for an annual performance incentive bonus, new hire equity, and ongoing performance-based equity.
Benefits
- Medical, dental, and vision insurance.
- 401k match.
- Flexible time off.
- Paid holidays, including year-end shutdown.