Sanofi Group Associate Director, Statistical Programming in Cambridge, Massachusetts
Associate Director, Statistical Programming
In this role you will provides leadership and support to project teams on all statistical programming matters according to the global project strategies within the assigned group (BU, or TSU/DPU). You will lead one or more projects for all programming deliverables through the project milestones from study start-up to regulatory submission and approval and post marketing support. Collaborate with statisticians and programmers across SOPs. Participate in the identification and development of programming standards and macros to facilitate the creation of statistical deliverables, as well as in process improvement activities geographic locations to ensure high quality and timely statistical programming deliverables; ensures compliance to internal standards and. Work with programming management to identify resource needs based on project milestones and deliverables. Act as mentor to junior staff with regard to programming techniques, project management and implementation of standards. Contribute to the recruitment process for programmer positions within the department, both contract and permanent.
Lead one or more programming projects following company standards, processes, tools and applications. Independently coordinate and oversee the preparation, execution, reporting and documentation of project analysis programming, proactively identifying issues and recommending solutions. Provide project management and technical guidance to ensure operational and technical excellence. Collaborate with statisticians and programmers to define and implement analysis requirements and electronic data submission strategies. Provide programming support for the development and QC of analysis datasets and outputs for individual study as well as integrated analyses.
Mentor junior level staff in programming practices, implementation of standards and project management.
Act as programming representative in a multidisciplinary study team to ensure timely and quality support for analysis and reporting of clinical trials up to regulatory approval, product launch and annual reports.
Develop data models, programming standards and codes, and training end users in the use of project standards to support programming deliverables that follow regulatory submission requirements.
Maintain knowledge of new technologies, industry standards, regulatory requirements, and CSO guidelines and SOPs. Implement the quality control procedures that are operationally optimized and in compliance with regulatory requirements.
Support department initiatives and task forces. Lead/participate in departmental or cross-functional working groups and process improvement activities.
Assist resource assessments based on in-depth project knowledge, milestones and deliverables. Implement global resourcing strategy with regard to the use of off-shore operations, outsourcing and insourcing. Effectively interact with external programming resources, including contributing to development and/or review of contract specifications and feedback on performance.
Master’s degree in Statistics, Computer Science, Mathematics, Engineering, Life Science or related field, and 10+ years of programming experience preferably in processing clinical trial data in the pharmaceutical industry or
Bachelor’s degree in Statistics, Computer Science, Mathematics, Engineering, Life Science or related field, and 10+ years of programming experience preferably in processing clinical trial data in the pharmaceutical industry
Advanced SAS programming skills in a clinical data environment with expertise in at least one, preferably multiple, therapeutic areas.
Thorough understanding of relational database structures and their correlation to submission ready database structures. Knowledge of CDISC data structure requirements.
Experience in development and implementation of standard methodology.
Proven ability to work collaboratively on interdisciplinary teams. Strong interpersonal skills that demonstrate initiative and motivation. Proven ability to solve complex problems. Excellent verbal and written communication skills in a global environment.
Strong skills in project management requiring no supervision. Ability to effectively organize and manage multiple assignments with challenging timelines, from project start-up through submission.
Knowledge of regulatory requirements concerning electronic submission standards and experience in delivering one or more submissions to regulatory authorities globally.
Knowledge of pharmaceutical clinical development in one or multiple therapeutic areas (i.e. therapeutic area endpoints, understanding of statistical concepts, techniques and clinical trial principles) and ability to lead regulatory submissions.
Ability to mentor junior staff in programming techniques, project management and communication.
Ability to project and embody company values in day to day operations.
Proficiency with UNIX, MS Office, statistical and graphics software packages such as SPLUS, JMP and programming languages such as C+, JAVA
Experience with Clintrials and/or Oracle Clinical
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.
Sanofi is a global healthcare leader focused on patients' needs, engaged in the research, development, manufacturing and marketing of therapeutic solutions focused on patients’ needs. Sanofi has core strengths in diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets and Sanofi Genzyme.
At Sanofi, our ambition is to be an integrated global healthcare company, focused on patients’ needs. Much more than just a leading pharmaceutical company, Sanofi is committed to transforming scientific innovations into solutions and services that protect health, enhance life, and respond to the needs of the 7 billion people in the world. We trust our ambition to guide and inspire us as we work to create a future with optimal health and wellness for everyone.
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.
Sanofi, Empowering Life