Principal Statistician - Research (Non-Clinical) at Sanofi in Cambridge, MA

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Job Description

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 At Sanofi, we chase the miracles of science to improve people&rsquo;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.
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 The Non-Clinical Efficacy and Safety (NCES) team, within the Global Biostatistics and Programming Department of Sanofi R&amp;D, contributes to reliability, scientific quality and optimization of Projects/Programs support from "target identification" to "compounds in development&rdquo; by providing appropriate non clinical statistical support for efficacy and safety internal or external studies for all R&amp;D entities. NCES main missions are:
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   Bring statistical expertise (Design of experiment, data analysis, interpretation) and take in charge data analyses for internal or external complex or Key studies for decision making
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   Validate the statistical aspects of Specific Pharmacology Reports written by scientists for the Dossier for all programs;
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   Review key presentations; support answers to Health Authorities on Research or preclinical topics
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   Contribute to the implementation of end-user statistical applications for routine analyses within labs.
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   Deliver statistical training (methodology and tools)
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   Determine optimal design and sample size in particular for in vivo experiments in the scope of Animal Welfare Committee (AWC)
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   Provide consulting, in particular publication review
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   Participate to Due diligence on request
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 As expert leader, you will be responsible for the methodological and statistical aspects of projects in Research for several therapeutics areas in a WorldWide team of about 10 dedicated statisticians.
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 Responsibilities:
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 Lead statistician on multiple complex projects regarding Non-Clinical Efficacy and Safety (NCES) related Research activities with minimal direction from group head.
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 <ul>
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   Accountable for all statistical aspects of NCES plans, studies and submissions activities (when applicable), including quality, relevance to external stakeholders (e.g. regulatory authorities, medical journals), and scientific validity
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   Mentor people working on the project. Promote teamwork, quality, operational efficiency, and innovation. Create productive work environment. Ensure project team compliance with SOPs and departmental standards.
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   Plan and track project activities, timelines, and resource use. Provide justification for planned resource needs. Seek to optimize resource utilization thru efficient and well-managed resource allocation and across projects or areas. Capacity to respond to unscheduled increase in project workload.
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   Provide technical guidance and mentoring to junior staff.
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   Ensure productive collaborations with other functions in the aligned project team and with other statistics project leaders and in communicating with senior leadership.
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   Represents statistics in regulatory meetings
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   Represent statistics in cross function working groups. Contribute to operation process optimization and provide inputs to statistics standards.
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 Education:
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   PhD/MS in statistics or related discipline a minimum of 6 years of pharmaceutical experience
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   Demonstrated strong study management, interpersonal and communication skill
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   Very good skills in R, SAS ; Rshiny knowledge would be appreciated.
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   Broad knowledge and good understanding of advanced statistical concepts and techniques
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   Broad knowledge of pharmaceutical development.
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   Broad Research knowledge
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   Proven experience in preclinical and Research development including submission
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   Experience in the relevant therapeutic area desired
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   Ability to represent Sanofi in cross-company activities such a consortiums or professional associations
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  </li>
 </ul>
 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 or 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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 At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
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 Pursue
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  progress
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 , discover
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  extraordinary
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 Better is out there. Better medications, better outcomes, better science. But progress doesn&rsquo;t happen without people &ndash; people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let&rsquo;s be those people.
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 At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
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 Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!
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AI Powered Job Insights

Exciting opportunity for a Principal Statistician in Research at Sanofi. This role is crucial for improving non-clinical efficacy and safety projects, making a significant impact in the pharmaceutical sector.

📍 Location: Cambridge, MA  
💼 Position: Principal Statistician - Research (Non-Clinical)  
⏰ Type: Full-time  
📅 Date Posted: 2024-07-13  

Role Summary:
- Lead statistician on non-clinical research activities, providing statistical expertise for projects.  
- Accountable for statistical aspects of NCES plans, studies, and submissions activities.  
- Mentor junior staff and promote teamwork, ensuring quality and operational efficiency.  

What You'll Do:
- Perform complex data analyses for internal or external studies.  
- Review and validate the statistical aspects of reports and regulatory submissions.  
- Collaborate cross-functionally, representing statistics in regulatory meetings and working groups.  
- Provide technical guidance and ensure compliance with departmental standards.  

What's Needed:
- PhD/MS in statistics or related discipline with a minimum of 6 years in pharmaceuticals.  
- Strong skills in R and SAS; knowledge of Rshiny is beneficial.  
- Proven experience in preclinical research development and excellent interpersonal communication skills.  
- Ability to engage with external stakeholders and represent Sanofi in professional forums.

Top Interview Questions

  • Q: Can you describe your experience with statistical methods as they relate to non-clinical research, particularly in the pharmaceutical field?

    A: In my previous role, I applied statistical methods such as ANOVA and regression analysis to evaluate the efficacy of new compounds during preclinical trials. I ensured that our statistical designs adhered to guidelines set forth by regulatory bodies, and I frequently collaborated with cross-functional teams to provide insights derived from data analysis, which informed key decision-making in our research projects.

  • Q: How do you ensure the quality and scientific validity of statistical analyses in your projects?

    A: I implement rigorous quality checks at multiple stages of data analysis. First, I ensure clear documentation of methodologies used in study design, and I validate all datasets for inconsistencies before analysis. Peer reviews and team discussions help enhance the validity of statistical models. I also make use of simulations to assess the robustness of our findings under various scenarios, ensuring reliable and valid conclusions.

  • Q: Describe a challenging statistical problem you faced in a project and how you resolved it.

    A: I encountered a situation where data from an in vivo study was highly skewed, making standard statistical methods unsuitable. To resolve this, I applied log-transformation to stabilize the variance and used non-parametric tests, which provided more reliable insights. This approach improved our ability to interpret the efficacy of the compound and maintain compliance with regulatory expectations.

  • Q: What strategies do you use to effectively mentor junior statisticians, and how do you promote collaboration within your team?

    A: I adopt a hands-on approach to mentorship by conducting regular one-on-one sessions where I share insights from my experiences while providing constructive feedback on their work. I encourage them to present their analyses to the team, fostering a collaborative environment where everyone can learn from each other. Team-building activities and shared goals help us maintain strong communication and ensure operational efficiency.

  • Q: How do you prepare for representational meetings with regulatory authorities regarding statistical aspects?

    A: Preparing for meetings with regulatory authorities requires a deep understanding of our statistical methodologies and results. I compile comprehensive summaries of our findings, addressing potential queries and formulating responses ahead of time. I also engage in strategic rehearsal sessions with my team to ensure clarity in communication. Staying updated on the latest regulatory guidelines allows me to tailor our presentation to meet expectations and demonstrate scientific validity.

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