CSL
Senior Director, Cardio & Renal Statistics Lead
CSL, King Of Prussia, Pennsylvania, United States, 19406
Senior Director, Cardio & Renal Statistics Lead
Join CSL’s R&D organization to accelerate innovation in Cardio & Renal therapeutic areas. This role provides strategic oversight for statistical contributions to clinical development, partnering closely with Clinical Development, Regulatory, Safety, and other key stakeholders. Key Responsibilities
Lead the Biostatistics function for Cardio and Renal Therapeutic Areas, ensuring 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 leadership, Regulatory, Safety, and other functions to integrate statistical strategy into clinical development plans, target product profiles, 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. Champion the use of advanced and innovative design approaches, including simulations and quantitative decision-making frameworks. 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. Qualifications And Experience
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. Competencies
Strong statistical methodology knowledge and clinical trial design expertise. Ability to collaborate and influence across functions and levels. Excellent communication and interpersonal skills. Experience with CDISC standards, programming oversight, and statistical operations. Strategic and analytical mindset with a focus on execution. Ability to work in a matrixed environment and lead through influence. About CSL Behring
CSL Behring is a global biotherapeutics leader focused on discovering, developing, and delivering innovative therapies for patients worldwide. The organization operates one of the world’s largest plasma collection networks and uses three strategic scientific platforms: plasma fractionation, recombinant protein technology, and cell and gene therapy. Benefits
For more information on CSL benefits visit
How CSL Supports Your Well-being | CSL. Equal Opportunity Employer
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit
Accessibility Statement.
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Join CSL’s R&D organization to accelerate innovation in Cardio & Renal therapeutic areas. This role provides strategic oversight for statistical contributions to clinical development, partnering closely with Clinical Development, Regulatory, Safety, and other key stakeholders. Key Responsibilities
Lead the Biostatistics function for Cardio and Renal Therapeutic Areas, ensuring 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 leadership, Regulatory, Safety, and other functions to integrate statistical strategy into clinical development plans, target product profiles, 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. Champion the use of advanced and innovative design approaches, including simulations and quantitative decision-making frameworks. 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. Qualifications And Experience
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. Competencies
Strong statistical methodology knowledge and clinical trial design expertise. Ability to collaborate and influence across functions and levels. Excellent communication and interpersonal skills. Experience with CDISC standards, programming oversight, and statistical operations. Strategic and analytical mindset with a focus on execution. Ability to work in a matrixed environment and lead through influence. About CSL Behring
CSL Behring is a global biotherapeutics leader focused on discovering, developing, and delivering innovative therapies for patients worldwide. The organization operates one of the world’s largest plasma collection networks and uses three strategic scientific platforms: plasma fractionation, recombinant protein technology, and cell and gene therapy. Benefits
For more information on CSL benefits visit
How CSL Supports Your Well-being | CSL. Equal Opportunity Employer
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit
Accessibility Statement.
#J-18808-Ljbffr