Could you be our next Principal Biostatistician?
The role is based in our King of Prussia, PA or Waltham, MA locations. This is a hybrid position and is onsite a minimum of 3 days per week. Position Purpose:You will lead components of statistical contribution to a clinical development program. The Principal Biostatistician will implement statistical strategies for clinical trials and regulatory submissions within the program, and is accountable for the statistical deliverables
Main Responsibilities:- Input to statistical strategy and ensure appropriate statistical methodologies applied to study design and data analysis for clinical trials and regulatory submissions
- Lead components and fully support Biostatistics conduct in study design, protocol development, data collection, data analysis, reporting, and submission preparation
- Author the initial statistical analysis plan for clinical trials and regulatory submissions. Be accountable for timely completion and quality of the statistical analysis plan.
- Support Biostatistics interactions with regulatory authorities (eg FDA, EMA, PMDA)
- Be responsible for interpreting analysis results and ensuring reporting accuracy
- 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.
- Be accountable for the TFL/CDISC package for study report and regulatory submission
- Provide statistical thought partnership for innovative study design and clinical development plans, including Go-No Go criteria and probability of technical success calculations
Minimum Qualifications and Experience Requirements:- PhD or MS in Biostatistics, Statistics
- 7+ years or relevant work experience in the pharmaceutical industry and/or CRO
- Experience either managing a CRO, or having worked in a CRO
- Experience providing statistical leadership at a study level
- Demonstrated statistical contribution in facilitating and optimizing clinical development
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 BenefitsFor more information on CSL benefits visit How CSL Supports Your Well-being | CSL.
To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging
