Sanofi Group Statistical Programming Project Leader in Bridgewater, New Jersey
At Sanofi, we have a shared commitment to bring innovation and rigor to our competitive program, from bench to bedside. Our global department invests in the development of all our team members, offering compelling career opportunities that value diversity of thought and abilities, to optimize overall success and have a meaningful impact on patients’ lives.
As Programming Project Leader, you will play a key role in supporting a growing pipeline across several therapeutic areas in Neurology and Immunology area, with emphasis on trial conduct and regulatory submissions.
You will provide leadership and guidance as the lead statistician programmer at the project/indication level in Neurology and Immunology area, accountable for all the plan and execution of statistical programming activities, including the submission of the data to Health Authorities. In addition to supporting the clinical portfolio, you will contribute advanced knowledge and technical skills either to the therapeutic area or departmental innovation or process improvement projects.
You will be supported by a Biostatistics and Programming Department that fosters people development, offering compelling career opportunities that value diversity of thought and abilities, to optimize overall success and have a meaningful impact on patients’ lives
Lead, guide and support statistical programming deliverables within a project to ensure high quality and timely, technical validity, compliance to internal standards, SOPs and regulatory requirements
With minimal direction from group head, plan 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
Lead regulatory submission activities, including electronic submission packages
Ensure standardization and consistency in specifications and programming deliverables across individual studies and for integrated analyses
Supervise the quality controls (QC) methods and processes for programming deliverables in both study and submission level activities
Mentor junior staff working on the project.
Promote teamwork, quality, operational efficiency, and innovation
Collaborate effectively with project statistician and with other functions in the aligned project team to achieve project goals; participate in clinical project meetings and provide inputs, whenever relevant
Lead oversight activities for outsourcing engagements; guide team members to effectively interact with external resources
Participate in departmental initiatives; provide inputs to programming standardization and process optimization
Capacity to respond to unscheduled increase in project workload
Find innovative ways: Identifying areas and processes that can be improved and finding new and innovative ways of increasing speed and efficiency of programming have always been a part of statistical programmer role.
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 industry.
Excellent 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 supervision.
Knowledge 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 submissions.
Ability to collaborate with external partners (CROs, Partners, etc.) and manage outsourced activities.
Excellent verbal and written communication skills in an English global environment; ability to have efficient exchanges with partners, service providers, and colleagues across geographical locations.
Strong skills that demonstrate initiative, motivation and teamwork in global interdisciplinary teams.
Ability and mindset to embrace change, innovate and continuously improve programming practice.
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.