Principal Biostatistician (UK/EU remote)

Proclinical is seeking a dedicated and experienced Principal Biostatistician to join a CRO. This role is pivotal in leading the Biostatistics and Programming activities for a program of studies of moderate complexity. The successful candidate will be responsible for ensuring the delivery of individual studies and the overall program on time, on budget, and to the required quality. This role is an excellent opportunity to work in a dynamic and supportive environment, contributing to the advancement and improvement of patients' lives.

Responsibilities:

• Leading Biostatistics and Programming activities for a program of studies.
• Providing biostatistical input into the design of the program, including study design, sample size calculations, and patient randomization schemes.
• Reviewing project database structures, edit checks, and data management coding conventions.
• Preparing statistical analysis plans, including the definition of derived data, and the design of statistical tables, figures, and data listings for clinical summary reports.
• Conducting statistical analysis, interpreting data, and reporting results.
• Writing statistical methods sections of integrated study reports and reviewing drafts.
• Supporting responses to regulatory questions on the design of the program, and any labelling claims following submission.
• Participating in presentations at client and investigator meetings.
• Preparing biostatistics input to research proposals, participating in proposal defense meetings, and making presentations at marketing meetings with prospective clients.
• Providing ongoing coaching and mentorship to team members.

Key Skills and Requirements:

• M.S. degree in stats., biostatistics, or related field with significant relevant experience in the pharmaceutical industry; or Ph.D. in stats., biostatistics, or related field with substantial relevant experience in the pharmaceutical industry.
• Background in oncology is required.
• In-depth knowledge of study designs, and statistical analysis applications in one or more therapeutic areas.
• Excellent verbal and written communication skills as well as interpersonal and project management skills.
• Excellent knowledge of clinical trials methodology, regulatory demands, stats. and statistical SW. packages, including SAS.
• Experience guiding a regulatory submission.Ability to translate clients' needs into statistical practice and educate clients in the use of stats.

If you are having difficulty in applying or if you have any questions, please contact Heidi Hennigan at h.hennigan@proclinical.com

Apply Now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.