Director and Senior Director Biostatistics - Hybrid - Boston, MA. (Relocation $ available)

About the Role - Serve as the biostatistics expert across clinical programs, providing strategic guidance across all phases

Responsibilities

Provide strategic guidance on optimizing trial designs for early-phase dose escalation and late-phase studies
Act as a biostatistics representative, coordinating with internal teams and external vendors to manage and execute statistical deliverables
Conduct statistical modelling to enable effective trial designs and address emerging statistical challenges
Contribute to protocol development, authoring or reviewing statistical sections, and ensuring alignment with statistical principles
Author or review statistical analysis plans for clinical trials, overseeing the development of tables, figures, and associated deliverables
Review electronic case report forms (eCRFs) to ensure compatibility with statistical analysis requirements
Offer statistical input for clinical documents and conduct QC/QA of statistical deliverables
Perform ad-hoc statistical analyses when necessary
Contribute to clinical study reports, including authoring statistical methods and interpreting study results
Lead statistical efforts supporting regulatory submissions, such as IND/NDA/MAA filings, ensuring thorough review of submission components and datasets
Address inquiries from regulatory bodies, such as the FDA or EMA, or other ethics committees
Support and contribute to the development of publications, including manuscripts, posters, and presentations
Lead standardization and process improvements within the Biostatistics team, including defining templates and setting standards
Represent the organization in discussions of statistical issues with external stakeholders, including regulatory bodies and partners
Participate in inspection readiness activities as required
Stay current in statistical methodologies and trial design practices, particularly in oncology-focused drug development

Required Skills, Experience and Education
PhD in statistics or a related discipline, or an MS with relevant experience
Minimum of 10 years of experience in the pharmaceutical or biotechsector
Required expertise in oncology
Proven track record in clinical trial design, analysis, and reporting
Experience with regulatory submissions (e.g., INDs, NDAs, MAAs)
Strong knowledge of clinical trial statistical methods and regulatory guidelines (FDA, EMA, ICH)
Proficiency in SAS and R for statistical programming
Experience in managing statistical aspects of multiple studies simultaneously
Familiarity with data standards (e.g., SDTM, ADaM)
Experience overseeing CRO-provided statistical services
Ability to work independently, address challenges proactively, and communicate statistical concepts effectively

Equal Opportunity Statement - We are an equal opportunity employer and value diversity. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

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