Principal Biostatistician

Waltham, MA - USA

Monthly Salary: Not Disclosed

Posted on: Yesterday

Vacancies: 1 Vacancy

Job Summary

CSLs R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration were building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide.

Could you be our next Principal Biostatistician The job is in our King of Prussia PA Waltham MA and Maidenhead UK office. This is a hybrid position and is onsite three days a week. You will report to the Director of Biostats.

You will lead components of statistical contribution to a clinical development program. The Principal Biostatistician implements the statistical strategies for the 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

Qualifications and Experience Requirements:

PhD or MS in Biostatistics Statistics
7 years or relevant work experience
Experience with CROs (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

#LI-HYBRID

Our Benefits

CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits from health care to financial protection so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family need help paying for emergency back up care or summer camp looking for mental health resources planning for your financial future or supporting your favorite charity with a matching contribution CSL has many benefits to help achieve your goals.

Please take the time to review our benefits site to see whats available to you as a CSL employee.

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 worlds largest plasma collection networks CSL Plasma. Our parent company CSL headquartered in Melbourne Australia employs 32000 people and delivers its lifesaving therapies to people in more than 100 countries.

We want CSL to reflect the world around us

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. Learn more Inclusion and Belonging CSL.

Do work that matters at CSL Behring!

Required Experience:

Staff IC