Senior Director, Cardio & Renal Statistics Lead

CSL Plasma•Waltham, MA

About The Position

CSL's R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration, we’re building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide. The Senior Director, Biostatistics leads the biostatistics function for Cadio and Renal Therapeutic Areas and provides strategic oversight for statistical contributions to clinical development. This role is responsible for statistical excellence in clinical development plans, trial planning, data analysis, interpretation and reporting, and regulatory interactions and submissions, while partnering closely with Clinical Development and other key stakeholders. The Senior Director manages a team of statisticians both internal FTEs and external FSPs, and contributes to innovation, operational quality, and cross-functional collaboration.

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)
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

Nice To Haves

Exposure to or leadership of statistical innovation initiatives preferred

Responsibilities

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.