Location
Waltham, MA | United States
Job description
Preclinical Statistical Project Leader, Global Biostatistics Sciences - Vaccines
Job Description:
The Preclinical Statistical Project Leader will assume statistical responsibility for methodological and statistical aspects of pre-clinical research in close collaboration with the Research Project Leader or scientists. He/she will provide critical contribution on the design and analysis so that accurate assessments are made for decision-making, while ensuring compliance with regulatory expectations. As a core objective, his/her responsibilities include but not limited to provide statistical support in R&D for pre-clinical work, bioassay and biomarker research.
The Preclinical Project Biostatistician will report to the Head of the Biostatistics Preclinical team and will be part of the Translational and Early Development (TED) unit inside the Global Biostatistical Sciences (GBS) team.
Key Responsibilities :
Acts as the lead statistician for different vaccine projects and provides support to the preclinical research team on statistical requests and on all relevant statistical matters.
His/her responsibility includes but not limited to:
Under minimal to no supervision, independently participates in project activities such as assist in preclinical development plan, decision-making meetings, integrated analyses and dossier preparation, submission (IND and CTD) and follow-up (publication),
Represent the Biostatistics group at extended research team meetings,
Links with other internal stakeholders as digital, data management, automatization, non clinical safety, translational, CMC, R&D compliance, CROs,
Acts as representative in internal initiatives within GBS,
Presents internally and externally topics related to statistical activity (e.g., conference, professional groups, …),
Might attend external meetings with regulatory agencies (e.g. FDA, EMA, etc.),
Represents Sanofi in external pre-clinical research collaborations.
Acts as the lead statistician at project level for new project indication, and provides support and leadership to project needs on all relevant statistical matters:
Contribute to the setup of the pre-clinical studies making sure data will be adequately captured and collected to address the study objectives.
Provides statistical expertise, including but not limited to:
Design of Experiments with regards to available information and assumptions of in vivo or in vitro preclinical studies and/or research and bioassay development,
Define the appropriate sample size, randomization plan, statistical methodology,
Perform the statistical analyses in due time and with quality according to project priorities,
Write statistical memos/reports, aligning on key messages with scientist for sound conclusions,
Proposes and performs ad ’hoc exploratory data analyses with existing data to address new research questions as part of the when applicable.
Develop the digital mindset and data science culture of internal stakeholders including but not limited to :
Contribute developing some statistical self-services solution for scientists,
Contribute to statistical trainings Support the digital evolution within its scope of activities,
Perform technology watch on data science topics and be the referent for the platform.
Management activity:
Collaborates with junior statisticians or contingent workers for the preparation and production of statistical report & analyses/programming.
Accountable for management of the activities that are outsourced to external partners (CROs)
Required Education/Experience:
Education: PhD Biostatistics or equivalent experience, or a related field
Experience: 3-6 years in pharmaceutical experience or biotechnology/pharmaceutical industry
Required Competencies
Sanofi core competencies:
Strive for Results (rigor, organization skills, time management)
Act for Change & Innovation (eager to learn and open-minded)
Commit to Customers
Cooperate Transversally (ability to work in a multi-cultural environment, Ability to work teams)
Thinking Strategically
Make Decisions
Job specific competencies:
Technical expertise in statistics, data science, statistical modelling, etc.
Capable of conducting research in developing novel methodologies to provide support to the dynamic discovery vaccine areas.
Statistical tools: SAS, R and/or Python, Office 365, Other statistical software’s (e.g. JMP, S+, East, PASS,…is a plus)
Statistical Leadership skills
Effective English communication skills (oral and written)
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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