Senior Director, Cardio & Renal Statistics Lead

Waltham, MA - USA

Monthly Salary: Not Disclosed

Posted on: 11 hours ago

Vacancies: 1 Vacancy

Job Summary

CSLs R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration were 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.

Key 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.

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 driven by our promise to save lives. Focused on serving patients needs by using the latest technologies we discover develop and deliver innovative therapies for people living with conditions in the immunology hematology cardiovascular and metabolic respiratory and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation recombinant protein technology and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.

CSL Behring operates one of the worlds largest plasma collection networks CSL Plasma. Our parent company CSL headquartered in Melbourne Australia employs 32000 people and delivers its lifesaving therapies to people in more than 100 countries.

To learn more about CSL CSL Behring CSL Seqirus and CSL Vifor visit and CSL Plasma at Benefits

For more information on CSL benefits visit How CSL Supports Your Well-being CSL.

You Belong at CSL

At CSL Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy we are able to better understand and connect with our patients and donors foster strong relationships with our stakeholders and sustain a diverse workforce that will move our company and industry into the future.

To learn more about inclusion and belonging visit 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 Experience:

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