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A leading CRO is seeking an experienced Principal Statistician to oversee biostatistics and programming activities across studies. You will be responsible for study design, data analysis, and preparing reports, contributing to impactful projects in a supportive environment that values work-life balance.
We have recently partnered with an award-winning CRO, who is looking for an experienced Principal Statistician to join their successful study delivery team. Any area of specialism will be considered.
How you will be a success
The Principal Biostatistician will be responsible for leading the Biostatistics and Programming activities of a program of studies of moderate complexity and / or high value with significant organizational impact. They will plan, monitor, organize, and review activities of biostatisticians and programmers, ensuring timely, budget-conscious, and high-quality delivery of individual studies and the overall program, maintaining consistency across studies. Regulatory interaction experience is preferred.
Responsibilities include providing biostatistical input into study design, protocol development, sample size calculations, patient randomization schemes, and statistical aspects of case report form design.
Review project database structures, edit checks, and data management coding conventions.
Prepare statistical analysis plans, define derived data, and design statistical tables, figures, and data listings for clinical summary reports.
Perform statistical analyses, interpret data, and report results.
Write the statistical methods sections of integrated study reports.
Review draft integrated study reports.
Support responses to regulatory questions regarding the program design and labeling claims following submission.
Participate in presentations at client and investigator meetings.
Prepare biostatistics input for research proposals and participate in proposal defense meetings, making presentations at marketing meetings with prospective clients.
Key Qualifications and Skills
MS or Ph.D. in statistics, biostatistics, or a related field.
Experience in statistics, biostatistics, or related areas.
Respiratory experience is highly desirable.
Accountable for leading Biostatistics and Programming activities for high-complexity or high-value studies.
Ongoing coaching and mentorship of team members.
Knowledge of clinical trial methodology, regulatory requirements, statistics, and statistical software (including SAS).
What you get in return
Opportunities for career progression and skill development in a flexible working environment that values work-life balance. They offer an excellent employment package and benefits tailored to the current market. The company fosters a supportive, family-like atmosphere.
Next steps : If interested, please apply now with your CV. The organization aims to onboard a new Statistician as soon as possible.
Not the right opportunity? Contact Aimee Weston at +44 7806 790645 for a confidential discussion about other potential roles.
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