Director, Biostatistics

Company Address500 Unicorn Park Dr, 3rd Floor, Woburn, MA, 01801 About Replimune GroupReplimune's mission is to revolutionize cancer treatment with therapies designed to activate a powerful and durable full-body anti-tumor response. Replimune is pioneering the development of novel tumor-directed oncolytic immunotherapies. We envision a world where cancer is a curable disease. Job DescriptionOverviewReplimune'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. We imagine a world where cancer is a curable disease. At Replimune, we live by our values: United:We collaborate for a common goal. Audacious:We are bold and innovative. Dedicated:We give our full commitment. Candid:We are honest with each other. People are at the center of everything we do, and when it comes to our employees, we make it personal. With a deep sense of purpose, an innovative and collaborative culture, and a competitive total rewards program, everyone at Replimune has a unique opportunity to contribute to meaningful work that could impact patients' lives. Join us as we reshape the future. Summary of Job DescriptionThe Director, Biostatistics provides statistical leadership in one or more indications, supporting clinical development planning and execution for multiple clinical trials. Performs statistical analysis, develops tracking systems to assess trial efficiency, interacts with clinical teams to determine protocol design, evaluates databases and statistical analysis programs, and maintains expertise in state-of-the-art methodologies. Ensures study designs are scientifically sound and meet regulatory requirements. This position is based in our Woburn office and offers a hybrid work model. Local candidates are expected to be on-site 3 days per week. ResponsibilitiesProvide statistical support for clinical development plans across multiple trials. Contribute to study protocols, develop analysis plans, and prepare tables/listings/figures. Assist in writing sections of clinical study reports and publications. Monitor and guide internal and CRO project activities, including timelines and resources. Participate in pre-IND and NDA/BLA activities. Utilize SAS for efficacy analyses and data validation when necessary. Develop and implement departmental standards and lead process improvements. QualificationsEducation: PhD or MS in Biostatistics or Statistics required. Experience and Skills: Minimum of 7 years' experience for PhD, or 9 years' for MS, as a statistician in pharma/biotech. Experience in oncology clinical trials, especially solid tumors; immuno-oncology knowledge is a plus. Proficiency in advanced study design and biostatistical methodologies. Experience with NDA/BLA eCTDs and global regulatory submissions; interaction with health authorities. Leadership experience as an independent lead statistician. Strong interpersonal, leadership, and communication skills; ability to work independently and collaboratively. Proficiency in SAS and other statistical programming languages.#J-18808-Ljbffr

Created: 2025-05-04