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Statistical Programming Project Leader

Company: Sanofi
Location: Bridgewater
Posted on: June 25, 2022

Job Description:

Job Summary:Lead one or more statistical programming project team(s) in the Rare Diseases and Rare Blood Disorder projects. Responsible for all programming activities at the project/indication level. In addition, contribute to the therapeutic area and department initiatives and task forces for innovation and process improvements.Major Responsibilities:Provide leadership, guidance, and hands-on support to ensure high quality and timely statistical programming deliverables within a project, ensure technical validity, compliance to internal standards and SOPs, regulatory requirementsPlan and execute statistical programming project activities, timelines, and resource use in cross-site global setting; provide justification for planned resource needs, seek to optimize resource utilization thru efficient and well-managed resource allocation and across projects or areas, with minimal direction from group head.Ensure standardization and consistency in specifications and programming deliverables across individual studies and for integrated analysesProvide technical guidance and leadership to metadata specifications and project/study specific data requirementsLead regulatory submission activities, including electronic submission packagesSupervise the quality controls (QC) methods and processes for programming deliverables in both study and submission level activitiesProvide guidance and mentor junior staff on programming techniques, project management and implementation of standardsCollaborate effectively with project statistician and with other functions in the aligned project team; participate in clinical project meetings and provide inputs, whenever relevantLead oversight activities for outsourcing engagements; guide team members to effectively interact with external resourcesParticipate in departmental initiatives; provide inputs to programming standardization and process optimizationRequired Education/Experience:Bachelor or Master of Science degree or equivalent in Statistics, Computer Science, Mathematics, Engineering, Life Science, or related field.MS / BS with at least 5 / 7 years of programming experience preferably in processing clinical trial data in the pharmaceutical industryExcellent technical skills in statistical programming, with advanced knowledge in SAS and other statistical computing software (R, R-Shiny)Ability to perform, coordinate and oversee the preparation, execution, reporting and documentation of all programming deliverables of a project, with minimal supervisionKnowledge on regulatory requirement evolution (SDTM, SDRG, ADRG, ADAM, XML format, etc.); thorough understanding of pharmaceutical clinical development (i.e., statistical concepts, techniques, and clinical trial principles) and ability to lead regulatory submissionsAbility to collaborate with external partners (CROs, Partners, etc.) and manage outsourced activitiesExcellent verbal and written communication skills in an English global environment; ability to have efficient exchanges with partners, service providers, and colleagues across geographical locationsStrong skills that demonstrate initiative, motivation, and teamwork in global interdisciplinary teamsAbility and mindset to embrace change, innovate and continuously improve programming practiceAt 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.As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health.This position will require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.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.GD-SALI-SAPDNAt 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.PDN-954f7cc5-48b8-42a6-bf99-746445c84475

Keywords: Sanofi, Trenton , Statistical Programming Project Leader, Other , Bridgewater, New Jersey

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