Senior Biostatistician Consultant - Remote

Senior Biostatistician

For the past 25 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners' most high-profile drug and device programs.

The Senior Biostatistician position is responsible for designing and executing statistical analyses, providing statistical expertise to cross functional teams, and ensuring the quality and accuracy of statistical deliverables.

Lead statistical activities for clinical trials and data analyses, including study design, statistical analysis plan development, and statistical analysis.

Provide statistical expertise to cross functional teams, including clinical operations, data management, and regulatory affairs.

Ensure the quality and accuracy of statistical deliverables, including statistical reports, tables, listings, and graphs.

Participate in the development and review of clinical study protocols and case report forms (CRFs) to ensure appropriate statistical analysis.

Develop and maintain SAS programs for statistical analysis in accordance with standard operating procedures (SOPs), good programming practices, and regulatory guidelines.

Keep up to date with regulatory guidelines and industry standards related to biostatistics and ensure compliance with these guidelines.

Strong project management skills, with the ability to manage multiple projects simultaneously.

Knowledge of regulatory requirements and guidelines related to statistical analysis and reporting of clinical trial data.

Ability to program in SAS and/or R.

3+ years of relevant work experience.

• Outsourcing industry experience required.
• Experience in clinical trial design, sample size calculations, and statistical analysis.
• Experience with CDISC data structures, such as SDTM and ADaM.

We are committed to diversity, equity, and inclusion. All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not.

Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager. All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office.

***Please, no phone calls or emails to anyone regarding this posting.***