? (15h Left) Associate Statistical Project Leader Position Available In Middlesex, Massachusetts

Job Description:

Job Title:

Associate Statistical Project Leader Location:

Morristown, NJ, Cambridge, MA About the Job Are you ready to shapethe future of medicine? The race is on to speed up drug discoveryand development to find answers for patients and their families.

Your skills could be critical in helping our teams accelerateProgress. Join our Biostatistics Immunology & Inflammation(I&I) as Associate Statistical Project Leader and you will leadseveral I&I phase 2 or 3 studies under minimum supervision ofstatistical project leader and/or team leader. You’ll haveopportunities to develop innovative statistical solutions tosupport critical trial decision-making and advance treatment acrossall phases of drug development. Within our department of EvidenceGeneration and Decision Science, you’ll be supported by aBiostatistics group that fosters people development, offeringcompelling career opportunities that value diversity of thought andabilities, to optimize overall success and have a meaningful impacton patients’ lives. We are an innovative global healthcare companywith one purpose: to chase the miracles of science to improvepeople’s lives. We’re also a company where you can flourish andgrow your career, with countless opportunities to explore, makeconnections with people, and stretch the limits of what you thoughtwas possible. Ready to get started?

Main Responsibilities:

• Provide high quality input into the design of the clinical study(including protocol development), the setup and conduct of thestudy to make sure data are adequately captured and collected toanswer the study objectives and to support the planned statisticalanalyses.
• Accountable for all statistical deliverables related tothe study: statistical sections in protocol including sample sizecalculation, randomization specifications, and statisticalmethodology, etc., Statistical Analysis plan, data surveillance,statistical analysis results for CSR and its appendices.
• Effectively utilize external groups, e.g. CROs or data monitoringcommittees (DMC).
• Work with the programming team to providedefinitions, documentation and review of derived variables, as wellas the quality control plan.
• Perform and/or coordinate with studyprogrammer the production of statistical analyses. Review andexamine statistical data distributions/properties.
• Overseeexecution of the statistical analyses according to the SAP, preparestatistical methods & provide statistical insight intointerpretation and discussion of results sections for the clinicalstudy report (CSR) and/or publications to ensure the statisticalintegrity and scientific validity of the content according tointernal standards and regulatory guidelines and in compliance withSOPs.
• Propose, prepare and perform exploratory data analyses,ad-hoc analyses as relevant for the study or project objectives.

About You

• PhD/MS in statistics or related discipline with atleast 3 years of pharmaceutical experience in clinical development,including experience with Biotech, pharma, Clinical ResearchOrganizations (CROs), health authorities and academic clinicalresearch centers
• Broad knowledge and good understanding ofadvanced statistical concepts and techniques; being able to doadvanced statistical analyses using SAS or R.
• Demonstrated stronginterpersonal and communication skills.
• Proficient in written andspoken English Why Choose Us?
• Bring the miracles of science tolife alongside a supportive, future-focused team.
• Discoverendless opportunities to grow your talent and drive your career,whether it’s through a promotion or lateral move, at home orinternationally.
• Enjoy a thoughtful, well-crafted rewards packagethat recognizes your contribution and amplifies your impact.
• Takegood care of yourself and your family, with a wide range of healthand wellbeing benefits including high-quality healthcare,prevention and wellness programs and at least 14 weeks’gender-neutral parental leave.

Sanofi Inc. and its U.S. affiliatesare Equal Opportunity and Affirmative Action employers committed toa culturally diverse workforce. All qualified applicants willreceive 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 militarystatus; domestic violence victim status; atypical cellular or bloodtrait; genetic information (including the refusal to submit togenetic testing) or any other characteristic protected by law.

GD-SA LI-SA

LI-Onsite vhd All compensation will be determinedcommensurate with demonstrated experience. Employees may beeligible to participate in Company employee benefit programs, andadditional benefits information can be found here.