Senior Biostatistics Leader, Clinical Development (Hybrid)

CSL; Waltham (MA); Hybrid; USD 212,000 - 251,000; Full time

Benefits offered by this job

Hybrid work arrangement

Equity

Incentive compensation

Job summary

CSL in Waltham, MA is seeking an Associate Director, Biostatistics to lead the full scope of statistical contributions to a clinical development program. You will define statistical strategies for trials and regulatory submissions and be accountable for statistical deliverables within the program.

This hybrid role requires a minimum of 3 days onsite weekly. Base salary ranges from $212,000 to $251,000 per year, with potential incentives and equity; relocation assistance is not provided.

Qualifications

• PhD or MS with extensive drug development experience
• Experience leading statistical efforts in clinical development
• Proven expertise in advanced statistical methodologies
• Experience with regulatory submissions and interactions with authorities

Responsibilities

• Lead full scope of Biostatistics conduct for the program and define statistical strategies.
• Collaborate with cross-functional teams for governance reviews.
• Lead statistical planning and quantitative evaluation for trials and regulatory documents.
• Provide statistical thought partnership for innovative study design and readiness for Go-No Go decisions.
• Ensure timely, high-quality deliverables and integrated analyses for submissions.
• Represent Biostatistics in interactions with regulatory authorities.
• Oversee outsourcing to CROs and internal programmers to ensure quality.
• Contribute to department improvement initiatives.
• Prepare abstracts, posters, and reports for internal and external stakeholders.

Skills

Leadership

Statistical leadership

Clinical development strategy

Regulatory submissions

Team collaboration

Communication (verbal/written) in ENG

Go-No Go criteria

Data analysis

Study design

Education

PhD in relevant field

MS in relevant field

Tools

SAS

R

Job description

CSL in Waltham, MA is seeking an Associate Director, Biostatistics to lead the full scope of statistical contributions to a clinical development program. You will define statistical strategies for trials and regulatory submissions and be accountable for statistical deliverables within the program.

This hybrid role requires a minimum of 3 days onsite weekly. Base salary ranges from $212,000 to $251,000 per year, with potential incentives and equity; relocation assistance is not provided.