Sanofi Group Application Development Lead, Statistical Programming, Bridgewater, NJ in Bridgewater, New Jersey

Provides technical leadership and application development support to project teams on all statistical programming matters involving standard tools and technologies utilized by the biostatistics & programming (B&P) user community.

Provides technical expertise in SAS graphics, R and other statistical computing software, and serve as a go-to person on programming technical issues. Provides project management and support to the development and evaluation of department applications, tools, and standards.

Serves as a B&P internal expert to provide sustained support on the future generation of B&P tools, leads the creation and maintenance of the B&P report template library in the implementation of B&P tools and applications.

Provides support and mentoring to the junior level staff with an emphasis on technical capabilities.

Responsibilities:

  • Collaborate with the ITS/systems group on the development and maintenance of tools and systems associated with department standards and technologies.    

  • Define and/or improve the strategy for the implementation of the global reporting standards in the department based on industry standards and regulatory requirements.

  • Lead the creation and maintenance of the department report template library in the implementation of department tools and applications.

  • Lead and/or contribute to programming development and quality control of the programming deliverables utilizing standard tools and methodologies. Mentor others on the use of department standard tools when programming clinical data or system application deliverables.

  • Create formatted output for use in clinical study reports, publications, presentations, submission and response to regulatory authority queries.

  • Provide user support of department tools and standards. Provide technical guidance to the project teams on all statistical programming matters involving standard tools and technologies related projects as needed.

  • Support department initiatives and task forces. Lead/participate in departmental or cross-functional working groups and process improvement activities.

  • Identify areas for improvement and recommend solutions related to systems, reporting tools, technologies, and best programming practices.

  • Actively participate in department working groups, provide input in development of tools applicable to process improvement.    

Required Education/Experience:

  • A candidate with a Master degree and 5+ years of programming experience preferably in processing clinical trial data in the pharmaceutical industry.

  • A candidate with a Bachelor degree and 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, R and other statistical computing software. Preferably with background in both statistics and computer science.

  • Demonstrated experience and strength in developing and maintaining statistical analysis and reporting tools / systems. Extensive understanding of reporting systems utilizing multiple data delivery applications.

  • Solid understanding of clinical trial data and the technical requirements of analysis and reporting in clinical trials.

  • Extensive experience in the development and execution of project user requirements, system design, validation plans, development and implementation.

  • Experience with other programming languages such as C++, Java, etc. typically used for software development in a global environment.

  • Strong understanding of pharmaceutical clinical development (i.e. understanding of statistical concepts, techniques and clinical trial principles) and ability to provide programming support needs for NDA and other regulatory submissions.

  • Understanding of regulatory requirements concerning electronic submission standards with particular emphasis on item 11 deliverables.

  • Knowledge of CDISC data structure requirements.

  • Understanding of relational database structures and their correlation to submission ready database structures.

  • Excellent project management skills. Ability to effectively organize and manage multiple assignments with challenging timelines for the development of tools to facilitate creation and execution of statistical deliverables by the end-user.

  • Collaborative teamwork and interpersonal skills that demonstrate initiative and motivation. Strong problem solving skills. Excellent verbal and written communication skills in a global environment.

  • Experience in collaboration with external partners and/or vendors.

  • Ability to estimate resource requirement.   

Preferred Education:

  • A candidate with an advanced degree in Statistics, Computer Science, Mathematics, Engineering, Life Science or related field, preferred

Sanofi US Services, 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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