Sanofi Group Senior Manager, Biostatistics (Early Development) in Bridgewater, New Jersey
As a statistician in the Biostatistics and Programming Department, integrated into a team of covering all of Sanofi's therapeutic areas (excluding oncology), with minimal direction from group head, you will be responsible for the methodological and statistical aspects of projects in early clinical development (including Proof of Concept studies) in order to optimize the early development plan and ensure its coherence, in compliance with procedures and guidelines.
As part of international project teams (eg, clinical, pharmacovigilance, regulatory affairs, marketing), contribute to the early development strategy, the management of the project, the preparation of the associated submission dossier and decision-making.
In interaction with the therapeutic units, carry out the project by acting as statistician of a study and/or coordinating the statisticians in charge of the different studies from the protocol to the study report.
Appropriately integrate the translational approach strategy into development plans and implement it.
Actively participate in writing clinical study synopsis/protocols, interpreting statistical analyses, and presenting results.
Review or produce the Statistical Analysis Plans and the statistical part of the study reports.
Define, produce, review, and integrate reports on project safety, pharmacodynamics or efficacy.
Participate in meetings with regulatory authorities; prepare submission dossier.
Provide/develop statistical expertise within the team, department or cross-functions with pharmacology, pharmacokinetics or pharmacometry teams.
Make proposals to improve designs, analyses and, more broadly, the efficiency and effectiveness of the department through continuous bibliographic monitoring.
Provide technical guidance and mentoring to junior staff; pilot contractors.
Promote team work.
Represent statistics to participate (and lead if applicable) in scientific or technology working groups or cross function initiatives.
Contribute to operation process optimization and provide inputs to statistics standard
Act as statistical consultant within company.
PhD or Master in mathematics /statistics, with specialization in Biostatistics.
Statistician with significant experience in the pharmaceutical industry (> 6 years) in the field of early clinical studies (up to and including Phase II), with experience as a biostatistics project manager. Experience in biomarker development, Phase IIb/III and submission would be appreciated.
Competencies Required :
High proficiency of clinical research and business strategy in this field; mastery of general regulatory guidelines, and specific to at least one therapeutic area.
Ability to understand clinical, regulatory and marketing issues and propose innovative/state-of-the art development plans, trial designs and analyses.
High proficiency of statistics used in the pharmaceutical industry in clinical development including statistical methods used for flexible designs as well as simulation technics; modeling and biomarker data mining skills.
Demonstrated strong project/study management, interpersonal and communication skills; strong capacity for anticipation, organization and coordination; leadership, including supervision of contractors; ability to work as a team player and interact with all stakeholders.
Familiar with state-of-the-art study designs and statistical methods.
Very good communication skills and good popularization skills for explaining the statistical methods used.
Good level of English mandatory for writing and speaking; experience in presentations.
Very good skills in R, SAS ; Rshiny knowledge would be appreciated.
Scientific and operational rigor.
Autonomous in the management of your activities; organized, able to efficiently manage multiple and variable deadlines. Capacity to respond to unscheduled increase in project workload.
Ability to represent Sanofi in cross-company activities such a consortiums or professional associations.
Open to Remote work
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.
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.