Principal Biostatistician
Location: Greater Philadelphia or Boston
Work Model: Hybrid (3 days onsite per week)
Our client is a global organization focused on advancing novel therapies for patients with rare diseases, with a clinical pipeline spanning multiple stages of development and therapeutic areas including immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Bringing a collaborative, project-driven structure, the organization is building a forward-looking team dedicated to delivering treatments that make a meaningful impact worldwide. Utilizing three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy, the company continually refines ways in which products can address unmet medical needs and help patients lead full lives.
Currently they are seeking a Principal Biostatistician to provide statistical leadership for clinical development programs. In this role, you will lead components of statistical contribution to clinical development programs, implement statistical strategies for clinical trials and regulatory submissions within the program and will be accountable for statistical deliverables. It’s a fantastic opportunity to become a part of a stable and growing group with a focus on innovation.
Responsibilities:
- Provide 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 (e.g. 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
Qualifications:
- PhD or MS in Biostatistics, Statistics
- PhD 4+/ MS 6+ 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
