CSL Plasma
Senior Director, Cardio & Renal Statistics Lead
CSL Plasma, King Of Prussia, Pennsylvania, United States, 19406
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 world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 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 https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.
Our 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 https://www.csl.com/careers/inclusion-and-belonging
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 https://www.csl.com/accessibility-statement.
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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 world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 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 https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.
Our 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 https://www.csl.com/careers/inclusion-and-belonging
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 https://www.csl.com/accessibility-statement.
#J-18808-Ljbffr