Safety Expert Statistician

6 years

Not Disclosed

Bridgewater Cambridge

Openings: 15 Posted: June 11, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Description: Safety Expert Statistician

Overview

Are you ready to shape the future of medicine? Join our Biostatistics team as a Safety Expert Statistician and support our V division with your safety data analysis talents to accelerate drug discovery and development.

Job Summary

Provide leadership and guidance as the lead statistician dedicated to safety on one or more safety monitoring teams. 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, also on an individual trial level.

Major Duties and Responsibilities

Leadership and Guidance: Lead safety signal detection, validation, characterization, and reporting for several projects with minimal direction from the group head.
Statistical Support: Provide direct statistical support and scientific leadership for clinical trial safety data within a project.
Quality Assurance: Accountable for all safety statistical deliverables for complex projects, ensuring quality, relevance to external stakeholders, and scientific validity.
Team Collaboration: Promote teamwork, quality, operational efficiency, and innovation. Ensure safety monitoring team compliance with SOPs and departmental standards.
Project Management: Plan and track project activities related to safety, timelines, and resource use. Provide justification for planned resource needs and optimize resource utilization.
Standard Harmonization: Lead discussions around the definition and harmonization of quality standards within and across therapeutic areas.
Mentorship: Provide technical guidance and mentoring to junior staff.
Cross-functional Collaboration: Ensure productive collaborations with other functions in the safety monitoring team and with other statistics project leaders.
Representation and Participation: Represent statistics in scientific or technology working groups or cross-functional initiatives. Contribute to operation process optimization and develop state-of-the-art methodology and standards for safety analyses.

About You

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

Why Choose Us?

Supportive Team: Bring the miracles of science to life alongside a supportive, future-focused team.
Career Growth: Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
Rewards Package: Enjoy a well-crafted rewards package that recognizes your contribution and amplifies your impact.
Health and Wellbeing: Take care of yourself and your family with a wide range of health and wellbeing benefits, including high-quality healthcare, prevention and wellness programs, and at least 14 weeks of gender-neutral parental leave.

Equal Opportunity

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 for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex; gender; gender identity or expression; affectional or sexual orientation; disability; veteran or military status; liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing); or any other characteristic protected by law.

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