Safety Expert Statistician

卡湯晩; Cambridge; On-site; GBP 60,000 - 90,000; Full time

Job summary

A leading company in pharmaceuticals seeks a lead statistician dedicated to safety for clinical trial data analyses. You will be responsible for ensuring the quality and compliance of safety statistical deliverables while mentoring junior staff. This role requires advanced knowledge of statistical methods and significant experience in the pharmaceutical industry.

Qualifications

• PhD/MS in statistics or similar with 6+ years pharmaceutical experience.
• Broad knowledge of advanced statistical concepts and techniques.
• Experience in safety signal detection and regulatory interactions.

Responsibilities

• Lead safety signal detection, validation, characterization, and reporting.
• Ensure quality and scientific validity of safety analyses.
• Provide technical guidance and mentoring to junior staff.

Skills

Project Management

Interpersonal Skills

Communication Skills

Epidemiology Methods

Bayesian Methodology

Education

PhD/MS in statistics or related discipline

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

• Lead safety signal detection, validation, characterization, and reporting for several projects with minimal direction from the group head. Provide statistical support and scientific leadership for clinical trial safety data within a project. Ensure the quality, relevance to external stakeholders (e.g., regulatory authorities, medical journals), and scientific validity of safety analyses.
• Accountable for all safety statistical deliverables for complex projects.
• Promote teamwork, quality, operational efficiency, and innovation. Ensure safety monitoring team compliance with SOPs and departmental standards.
• Plan and track project activities related to safety, timelines, and resource use. Provide justification for resource needs. Optimize resource utilization across projects and respond to workload increases.
• Lead discussions on defining and harmonizing quality standards at both the trial and project levels within and across therapeutic areas.
• Provide technical guidance and mentoring to junior staff.
• Ensure productive collaboration with other functions in the safety monitoring team and with other statistical project leaders. Communicate effectively with senior leadership.
• Represent the statistics team in scientific or technological working groups or cross-functional initiatives. Contribute to process optimization and develop 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 a 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 or external stakeholders.
• 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 diverse workforce. All qualified applicants will receive consideration without regard to race, color, creed, religion, national origin, age, marital status, gender identity or expression, sexual orientation, disability, veteran or military status, genetic information, or other protected characteristics.

At Sanofi, diversity and inclusion are foundational to our operations and embedded in our core values. We strive to create an inclusive workplace where differences are celebrated and leveraged to empower our colleagues, patients, and customers.

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

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

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