Regulatory Affairs à Grande-Bretagne

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it's the best of both worlds....

ClinChoice is searching for a HYBRID Principal Biostatistician to join our biometrics team. This is a full-time permanent opportunity with HYBRID option in Stirling, UK.

ClinChoice is a global full-service CRO with a strong focus on quality, professional development and supportive culture. We are recruiting for a Principal Biostatistician, who will be responsible for protocol development and statistical analysis plan for assigned studies. Additional tasks include provide statistical oversight to studies and assure adequate quality and consistency with project requirements.

Job Responsibilities

• Responsible for protocol development including study design, sample size calculation, randomization, and statistical analysis plan for assigned studies.
• Provide statistical oversight to studies and assure adequate quality and consistency with project requirements.
• Responsible for assuring that data for statistical analyses are complete, accurate and consistent.
• Responsible for statistical analysis plans and the accuracy and timeliness of statistical input into reports or decisions.
• Responsible for validity of analysis and explore alternative analysis strategies as needed.
• Demonstrates extensive understanding of statistical concepts and methodologies. Recognizes and corrects flaws in scientific reasoning and statistical interpretation.
• Responsible for accuracy and consistency of statistical tables, figures, and data listings, accuracy of report text, and consistency between summary tables in the body of reports and the corresponding source tables and listings.
• Responsible for statistical methods section for the reports. Identifies and corrects common flaws in interpretation of results, inconsistency in presentation or inference, adherence to the report guidelines, and assures project-wide consistency.
• Effectively mentor peers with regards to statistical methodology and provide appropriate training to less experienced statisticians.
• Manage activities of statisticians across projects by appropriately coordinating assignments and reviewing work so that projects are delivered on time with high quality.

Requirements:

• MS or PhD in Statistics, Biostatistics or related field. PhD with 3-5 years of experience or MS with 7-8 years of experience.
• Strong oral and written communications skills, with ability to effectively communicate internally and with clients.
• Demonstrated understanding and insight in statistics, drug development process and relevant FDA regulations.
• Pharmaceutical, CRO, or related industry experience with clinical trials, including interaction with Regulatory Agencies, especially FDA.

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

Who will you be working for?

About ClinChoice

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

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