Safety Expert Statistician

TN United Kingdom; Cambridge; Hybrid; GBP 60,000 - 100,000; Full time

Job summary

An established industry player is seeking a lead statistician to enhance safety monitoring in clinical trials. This role involves providing statistical leadership, ensuring compliance with high-quality standards, and collaborating with cross-functional teams. You will lead safety signal detection and reporting, mentor junior staff, and communicate effectively with senior leadership. If you are passionate about making a difference in healthcare and possess a strong background in statistics, this is an exciting opportunity to contribute to groundbreaking projects.

Qualifications

• PhD/MS in statistics or related discipline with 6+ years of experience.
• Broad knowledge of advanced statistical concepts and techniques.

Responsibilities

• Lead safety signal detection and reporting for clinical trial data.
• Provide statistical leadership and ensure high-quality safety analysis.

Skills

Statistical Analysis

Project Management

Communication Skills

Epidemiology

Bayesian Methodology

Education

PhD/MS in Statistics

Job description

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At Sanofi, we chase the miracles of science to improve people’s lives. We believe our cutting-edge science and manufacturing, fueled by data and digital technologies, have the potential to transform the practice of medicine, turning the impossible into possible for millions of people.

Job Summary

Provide leadership and guidance as the lead statistician dedicated to safety on one or more safety monitoring team(s), accountable for all methodological and statistical aspects for safety data analyses around pooled clinical trial data of project(s). Act as a statistical consultant within the company for safety analyses, both at the individual trial level and across projects.

Major Duties and Responsibilities

1. Lead safety signal detection, validation, characterization, and reporting for several projects with minimal direction from the group head; provide statistical scientific leadership for clinical trial safety data within a project. Ensure statistical aspects for safety analysis are of high quality, relevant to external stakeholders (e.g., regulatory authorities, medical journals), and scientifically valid.
2. Accountable for all safety statistical deliverables for complex projects.
3. Promote teamwork, quality, operational efficiency, and innovation. Ensure safety monitoring team compliance with SOPs and departmental standards.
4. Plan and track project activities related to safety, timelines, and resource use. Provide justification for resource needs. Optimize resource utilization through efficient management and response to workload fluctuations.
5. Lead discussions on the definition and harmonization of quality standards at the individual trial level within and across therapeutic areas.
6. Provide technical guidance and mentorship to junior staff.
7. Ensure productive collaboration with other functions in the safety monitoring team and with other statistical project leaders. Communicate effectively with senior leadership.
8. Represent statistics in scientific or technological working groups or cross-functional initiatives. Contribute to process optimization. Develop and promote state-of-the-art methodologies and standards for safety analyses.

Required Education/Experience

• PhD/MS in statistics or related discipline with at least 6 years of pharmaceutical experience. Knowledge of epidemiology methods and concepts in safety context.
• Strong project/study management, interpersonal, and communication skills.
• Broad knowledge of advanced statistical concepts and techniques, including Bayesian methodology.
• Experience in clinical development or post-marketing activities such as submissions and interactions with regulatory agencies.
• Experience in safety signal detection is desired.
• Ability to represent Sanofi in cross-company activities such as consortiums or professional associations.
• Ability and mindset to embrace change, innovate, and continuously improve practices.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration without regard to race, color, creed, religion, national origin, age, ancestry, marital or civil partnership status, sex, gender, sexual orientation, disability, veteran status, or any other characteristic protected by law.

At Sanofi, diversity and inclusion are foundational to our operations and embedded in our Core Values. We recognize that embracing diversity and fostering inclusion are essential to empowering our colleagues, patients, and customers. We celebrate the diversity of our people, backgrounds, and experiences, providing equal opportunity for all.

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Our Mission

Better is out there. Better medications, better outcomes, better science. Progress requires people from diverse backgrounds, locations, and roles, united by the desire to make miracles happen. Let’s be those people.

At Sanofi, we are committed to equal opportunities for all, regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability, or gender identity.

Watch our video and learn more about our Diversity, Equity, and Inclusion initiatives!