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Associate Statistical Project Leader - Oncology

Sanofi

Sanofi

Cambridge, MA, USA
Posted on Thursday, August 17, 2023

Associate Statistical Project Leader - Oncology

Cambridge, Massachusetts, , Bridgewater, New Jersey

Overview

From Research and Development to Sales and Marketing, Sanofi offers a wide range of possibilities. Discover our open positions and become a health journey partner.

Success Profile

Do you have what it takes for a successful career with Sanofi?

  • Courageous
  • Results-driven
  • Proactive
  • Problem-Solver
  • Leadership
  • Team player

Culture: Play to Win

  • Growth

  • Innovation

  • Efficiency

  • Collaboration

Benefits

  • Health & Wellness

    Comprehensive coverage including medical, dental, vision, and health and wellness programs.

  • Financial

    Sanofi wants to ensure employees are equipped for financial health, Sanofi provides a competitive 401K Match program and Financial Wel-Being Tools and Programs.

  • Culture

    At Sanofi, we demonstrate our commitment to inclusion and diversity through Culture groups and programs. There are many ways to make a difference and connect with other Sanofi employees: including ERG groups and 2 PAID days off to Volunteer.

  • Work/Life Balance

    Sanofi provides significant Work/Life benefits to help you excel beyond the workday. Including Workplace Flexibility through part‑time, remote work, flex‑time and job share options.

Quote

"At Sanofi, We are guided by a deep appreciation and understanding of what it means to live with a rare blood disorder, and we learn by listening to the community – patients, caregivers physicians, and other healthcare professionals."

Shannon Resetich US Head Rare Diseases & Blood Disorders

"Patients are at the center of all that we do at Sanofi. Our teams are focused on advancing transformational therapies that can address serious unmet needs for people living with rare blood disorders, and expanding global patient access to our medicines."

Mouhamed Gueye US Head Medical Rare Blood Disorders

Responsibilities

Job Summary

Lead one or several studies in Oncology Therapeutic Area, under minimum supervision of statistical project leader and/or team leader.

Major Duties and Responsibilities

  • Provide support and leadership to the clinical trial study and/or project team on all relevant statistical matters:

  • Provide high quality input into the design of the clinical study (including protocol development) and/or clinical development plan (CDP) for early phase project, the setup and conduct of the study to make sure data are adequately captured and collected to answer the study objectives and to support the planned statistical analyses,

  • Accountable for all statistical deliverables related to the study: statistical sections in protocol including sample size calculation, randomization specifications, and statistical methodology, etc., Statistical Analysis plan, data surveillance, statistical analysis results for CSR and its appendices (TLGs and in-text tables)

  • Accountable for statistical aspects of clinical development plan a strategy for standard non-oncology early development projects

  • Effectively utilize external groups, e.g., CROs or data monitoring committees (DMC).

  • Work with the programming team to provide definitions, documentation and review of derived variables, as well as the quality control plan,

  • Perform and/or coordinate with study programmer the production of statistical analyses. Review and examine statistical data distributions/properties,

  • Oversee execution of the statistical analyses according to the SAP, prepare statistical methods & provide statistical insight into interpretation and discussion of results sections for the clinical study report (CSR) and/or publications to ensure the statistical integrity of the content according to internal standards and regulatory guidelines and in compliance with SOPs.

  • Propose, prepare and perform exploratory data analyses, ad-hoc analyses as relevant for the study or project objectives.

  • Review submission documents, such as IND, NDA, BLA, CTE or cTD to insure statistical validity and accuracy

  • Contribute to define and review the specific deliverables related to Transparency and Disclosure

  • Provide technical guidance to junior staff.

  • Plan and track study/project activities and timelines.

  • Ensure productive collaborations with other functions in the aligned study team, promoting teamwork, quality, operational efficiency, and innovation.

  • Represent statistics to participate in scientific or technology working groups or cross function initiatives; Contribute to operation process optimization and provide inputs to statistics standards.

Required Education/Experience

  • PhD/MS in statistics or related discipline with at least 3 years of pharmaceutical experience

  • Good knowledge of pharmaceutical clinical development, together with Late Phase and/or early Phase experience.

  • Broad knowledge and good understanding of advanced statistical concepts and techniques

  • Able to work in departmental computing environment, can do advanced statistical analyses using SAS and possibly other languages (R, …)

  • Demonstrated strong interpersonal and communication skills

At Sanofi R&D North America, we deliver meaningful solutions for patients. We transform science into breakthrough, best-in-class and first-in-class medicines and vaccines. We believe in creating a diverse and inclusive workforce – and workplace – which brings together the collective brainpower of over 2,000 colleagues and provides you with an exciting place to grow and develop. We set the bar high, and we deliver. Join us and together we will build on our trusted legacy of breakthroughs for society.

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.

As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.

According to the CDC, an individual is considered to be “fully vaccinated” fourteen (14) days after receiving (a) the second dose of the Moderna or Pfizer vaccine, or (b) the single dose of the J&J vaccine. Fully vaccinated, for new Sanofi employees, is to be fully vaccinated 14 DAYS PRIOR TO START DATE.

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#LI-SA

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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