Senior Director, Cardio & Renal Statistics Lead
CSL
full-time
Posted on:
Location Type: Office
Location: King of Prussia • Massachusetts, Pennsylvania • 🇺🇸 United States
Visit company websiteJob Level
Senior
Tech Stack
Go
About the role
- Lead the Biostatistics function for the assigned Cardio and Renal Therapeutic Area (TA), with accountability for statistical deliverables across all stages of clinical development.
- Provide statistical thought leadership to Clinical Development teams in the design of clinical development plans, and clinical trials, ensuring robust methodology and alignment with program objectives.
- Partner with Therapeutic Area (TA) leadership, Regulatory, Safety, and other functions to integrate statistical strategy into clinical development plans (CDPs), target product profiles (TPPs), and regulatory submissions.
- Ensure high-quality statistical input into study protocols, analysis plans, clinical study reports, and regulatory documentation.
- Represent Biostatistics in interactions with regulatory authorities (e.g., FDA, EMA, PMDA) and contribute to preparation of statistical content in submission dossiers.
- Champions the use of advanced and innovative design approaches, including simulations and quantitative decision-making frameworks (e.g., Go/No-Go criteria, assurance).
- Collaborate with other functions (e.g., Epidemiology, Safety) on initiatives such as real-world evidence and patient safety analysis.
- Manage, develop, and mentor statisticians within the therapeutic area to build technical capabilities and ensure delivery excellence.
- Build relationships and oversee external vendors and CROs to ensure quality and compliance with timelines and standards.
- Contribute to departmental strategy, process improvement, and the advancement of statistical methodology and operations.
Requirements
- PhD in statistics or related field
- 10+ years of experience in clinical development within the pharmaceutical or biotechnology industry
- Demonstrated leadership in statistical contributions to clinical programs and regulatory submissions
- Experience partnering with cross-functional teams and interacting with health authorities
- People management experience required; mentorship and team-building strongly preferred
- Experience managing external partners (CROs, consultants)
- Exposure to or leadership of statistical innovation initiatives preferred
Benefits
- For more information on CSL benefits visit How CSL Supports Your Well-being | CSL
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
biostatisticsclinical developmentstatistical methodologyclinical trials designregulatory submissionsdata analysisstatistical programmingreal-world evidencequantitative decision-makingsimulation techniques
Soft skills
leadershipmentorshipteam-buildingcollaborationcommunicationrelationship managementstrategic thinkingprocess improvementaccountabilityproblem-solving
Certifications
PhD in statisticsrelated field