Bring your statistical expertise to research that could shape the future of immunology. As an embedded Lead Biostatistician, you’ll partner with a global biotech team focused on autoimmune disease, helping turn complex data into insights that support better decisions for patients.
Compensation
The salary range estimated for this position based in Massachusetts is $135,000.00–$175,000.00. This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy.
Responsibilities
Design and implement statistical methodologies for complex clinical trials and research projects
Collaborate with cross-functional teams
Provide strategic guidance on study design and analysis
Contribute to significant research
Support advanced statistical tools and methodologies
Manage all clinical operational and quality aspects of allocated studies, of low to moderate complexity, in compliance with ICH GCP.
Develop clinical tools (e.g. Monitoring Plan, Monitoring Guidelines) in conjunction with the Data Quality Plan.
Contribute to the development of the Master Action Plan (MAP) for providing clinical related documents.
Ensure timely set up, organization, content and quality of the relevant sections of the Trial Master File (local and central).
May participate in the design and development of CRFs, CRF guidelines, patient informed consent templates and other protocol specific documents as required.
Manage all clinical operational and quality aspects of allocated studies, of low to moderate complexity, in compliance with ICH GCP.
Develop clinical tools such as Monitoring Plan and Monitoring Guidelines in conjunction with the Data Quality Plan.
Contribute to the development of the Master Action Plan (MAP) for providing clinical related documents.
Ensure timely set up, organization, content and quality of the relevant sections of the Trial Master File (local and central).
May participate in the design and development of CRFs, CRF guidelines, patient informed consent templates and other protocol specific documents as required.
Requirements
Bachelor's degree or equivalent and relevant formal academic / vocational qualification
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