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Proclinical is seeking a Principal Biostatistician to lead programming activities for a program of studies. This role involves contributing to study design, statistical analysis, and regulatory submissions while ensuring consistency and quality across projects. You will work in a collaborative environment, mentoring team members and supporting client interactions.
Responsibilities:
* Lead biostatistics and programming activities for complex or high-value programs.
* Provide statistical input into study designs, including protocol development, sample size calculations, and randomization schemes.
* Review database structures, edit checks, and data management coding conventions.
* Develop statistical analysis plans, including defining derived data and designing tables, figures, and listings for clinical reports.
* Perform statistical analyses, interpret data, and report results.
* Write and review statistical methods sections of integrated study reports.
* Support responses to regulatory questions and contribute to labelling claims post-submission.
* Participate in client and investigator meetings, including presentations.
* Contribute to research proposals and participate in proposal defense meetings.
* Mentor and coach team members to foster professional growth.
Key Skills and Requirements:
* Advanced degree in statistics, biostatistics, or a related field.
* Strong understanding of statistical principles, experimental design, and regulatory requirements.
* Proficiency in statistical software packages, particularly SAS.
* Experience leading regulatory submissions.
* Excellent communication, interpersonal, and project management skills.
* Ability to translate client needs into statistical practices and educate stakeholders on statistical concepts.
If you are having difficulty in applying or if you have any questions, please contact Dean Fisher at d.fisher@proclinical.com.
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
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