Responsibilities:
1 Input to statistical strategy and ensure appropriate statistical methodologies applied to
study design and data analysis for clinical trials and regulatory submissions.
2 Lead components and fully support Biostatistics conduct in study design, protocol
development, data collection, data analysis, reporting, and submission preparation.
3 Author the initial statistical analysis plan for clinical trials and regulatory submissions. Be
accountable for timely completion and quality of the statistical analysis plan.
4 Support Biostatistics interactions with regulatory authorities (eg FDA, EMA, PMDA)
5 Be responsible for interpreting analysis results and ensuring reporting accuracy.
6 Manage outsourcing operations or work with internal statistical programmers within the
responsible projects. Ensure timeliness and quality of deliverables by CRO/FSP. Conduct
reviews of deliverables to ensure quality.
7 Be accountable for the TFL/CDISC package for study report and regulatory submission.
8 Provide statistical thought partnership for innovative study design and clinical
development plans, including Go-No Go criteria and probability of technical success
calculations
9 Support or lead improvement initiatives within the department, organization and/or
pharma industry
Qualifications:
-PhD with 5 years of experience or MS with 8 years of experience in drug
development
-Experience providing statistical leadership at a study level
Demonstrated statistical contribution in facilitating and optimizing clinical
development
-Experience with CROs (either managing a CRO, or having worked in a CRO) or
managing internal deliveries preferred
-Experience supporting regulatory interactions or submissions preferred
Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.
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.