What are the responsibilities and job description for the Director, Biostatistics position at Replimune, Inc.?
Overview
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 patient’s 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, a competitive and forward-looking total rewards program, everyone at Replimune has a unique opportunity to contribute to the meaningful work we do which could impact the lives of patients.
Join us, as we reshape the future.
Summary of job description:
The Director, Biostatistics provides statistical leadership in one or more indications, including support of clinical development planning and execution for multiple clinical trials. Performs statistical analysis and develops tracking systems to determine the efficiency of clinical trials. Interacts with clinical development team to determine protocol design. Evaluates databases and statistical analysis programs. Maintains expertise in state-of-the-art data statistical methodologies and statistical analyses. At the project level, the individual in this role ensures the study designs are scientifically sound and that the efficacy and safety endpoints meet regulatory requirements.
This position is based in our Woburn office and welcomes hybrid work! Local candidates are expected to be on-site 3 days per week.
Responsibilities
Key responsibilities:
- Provide statistical support to clinical development plan for multiple clinical trials
- At study level, provide statistical input to study protocols, develop statistical analysis plan, and tables/listings/figures
- Assist in writing relevant sections of the clinical study report and publications
- Monitor and guide internal and CRO project activities including timelines, deliverables and resources
- Participate in pre-IND and NDA/BLA activities
- Ability to use SAS to perform efficacy analyses and validate important data derivations when necessary.
- Develop and implement department standards and lead process improvements
Other Responsibilities:
- Other duties as assigned
Qualifications
Education Requirements:
- PhD or MS in Biostatistics or Statistics required
Experience and Skill Requirements:
- At least seven (7) years’ experience for PhD, or nine (9) years’ experience for MS as statistician in the pharmaceutical or biotechnology industry.
- Oncology (especially solid tumor) clinical trail experience preferred; knowledge of immuno-oncology is a plus.
- Experience with advanced study design and up-to-date biostatistical methodologies.
- Experience of NDA/BLA eCTDs or other global regulatory submissions. Experience of direct interaction with health authorities.
- Experience as an independent lead statistician with responsibility for multiple studies or projects.
- Excellent interpersonal, leadership and communication skills and ability to work independently and collaboratively.
- Good knowledge of statistical programming languages (including SAS).
- Knowledge of SDTM/ ADaM.
