Role Summary
The Senior Biostatistician provides, and may lead, statistical contributions to a clinical development program. The Principal Biostatistician implements statistical strategies for clinical trials and regulatory submissions within the program and is accountable for all statistical deliverables.
Main Responsibilities and Accountabilities
Contribute to the statistical strategy and ensure appropriate statistical methodologies are applied to study design and data analysis for clinical trials and regulatory submissions.
Provide statistical support for data collection, analysis, reporting, and submission preparation.
Ensure the timely completion and quality of the Statistical Analysis Plan (SAP).
Support Biostatistics interactions with regulatory authorities (e.g., FDA, EMA, PMDA).
Interpret analysis results and ensure accuracy and clarity of reporting.
Manage outsourced statistical activities or collaborate with internal statistical programmers; ensure the timeliness and quality of CRO/FSP deliverables and conduct quality reviews.
Oversee preparation of Tables, Figures, and Listings (TFLs) and CDISC packages for study reports and regulatory submissions.
Support continuous improvement initiatives and contribute to standards related to infrastructure, processes, and scientific consulting.
Job Qualifications and Experience Requirements
Education
PhD or MS in Biostatistics, Statistics, or a related field
Experience
PhD with at least 3 years of experience in drug development, or
MS with at least 6 years of experience in drug development
Competencies
Advanced knowledge of statistical methodologies in clinical development
Ability to collaborate effectively and provide leadership in a matrix environment
Strong interpersonal and communication skills (written and verbal in English)
Proficiency in SAS and/or R
Familiarity with relevant regulatory guidance documents
Technical Expertise
CDISC standards, statistical programming, and/or data standards
Biostatistics and Statistical Programming Operations
CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patientsā 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 worldās 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 ViforĀ 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.
Ā 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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