Sanofi Group Sr. Manager, Programming in Bridgewater, New Jersey
Sr. Manager, Programming
Sanofi, a global healthcare leader, discovers, develops and distributestherapeutic solutions focused on patients’ needs. Sanofi has core strengths indiabetes solutions, human vaccines, innovative drugs, consumer healthcare,emerging markets, animal health and Genzyme.
At Sanofi US, we are committed to the growth of our people, connected inpurpose by career, life and health.
Headquartered in Bridgewater, NJ, Sanofi US is part of a leading globalhealthcare company dedicated to discovering, developing and distributingtherapeutic solutions focused on patients’ needs.
Sanofi has core strengths in diabetes solutions, human vaccines,innovative drugs, consumer healthcare, emerging markets, animal health andGenzyme.
Sanofi US employs approximately 17,000 people across the country alldedicated to protecting health, enhancing life and responding to the hopes andpotential healthcare needs of seven billion people around the world.
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Sanofi US Services, Inc. and its U.S. affiliates are Equal Opportunityand Affirmative Action employers committed to a culturally diverseworkforce. All qualified applicants will receive consideration foremployment without regard to race; color; creed; religion; national origin;age; ancestry; nationality; marital, domestic partnership or civil unionstatus; sex, gender, gender identity or expression; affectional or sexualorientation; disability; veteran or military status or liability for militarystatus; domestic violence victim status; atypical cellular or blood trait;genetic information (including the refusal to submit to genetic testing) or anyother characteristic protected by law.
The Senior Manager in statistical programming providestimely support to the project teams on all programming matters according to theglobal project strategies. As anintegral part of a project team, the incumbent provides project leadership andcontributes to the programming support for processing data from clinicalstudies. The incumbent providesdirections and leadership to internal staff and external partners on outsourcedprojects. The incumbent assists in the analysis of resources and works withmanagement to distribute work based on priorities, timelines and study designcomplexity. The incumbent facilitatesthe management of project resource allocation, manages tool development insupport of project requirements and contributes to the production of programmingdeliverables. The incumbent isresponsible for screening and interviewing viable candidates for positionswithin the statistical programming department, both contract and permanent.
Coordinate and oversee the programming and QC ofanalysis datasets following sanofi standard data models. Integration of data across studies in supportof CSS/CSE. Create, manage and maintainthe programming specifications for the analysis datasets utilizing sanofi toolsand methodologies.
Collaborate with external partners and/orvendors on all statistical programming matters.
Manage the programming/system deliverables usingappropriate tools to track, allocate and summarize extent of work required,progress and completion of programming deliverables.
Contribute to programming development andquality control of the programming deliverables utilizing sanofi tools andmethodologies.
Work in a multidisciplinary study team toprovide timely and quality support for analysis and reporting of clinical trialsup to regulatory approval, product launch and annual reports.
Review and select resumes, screen and interviewcandidates for contractor and permanent positions.
Required Educationand Experience:
- Bachelor degree and 9 years of programming experience preferably in processing clinical trial data in the pharmaceutical industry.
Experience in delivering one or more submissionsto regulatory authorities.
Excellent project management skills. Abilityto effectively organize and manage multiple assignments with challengingtimelines.
Demonstrated experience and strength in collaborationwith external partners and/or vendors on statistical programming matters.
Collaborativeteamwork and interpersonal skills that demonstrate initiative andmotivation. Strong problem solvingskills. Excellent verbal and writtencommunication skills in a global environment.
Extensive knowledge of pharmaceutical clinicaldevelopment (i.e. understanding of statistical concepts, techniques, clinicaltrial principles) and ability to provide programming support needs for NDA andother regulatory submissions.
Knowledge of regulatory requirements concerningelectronic submission standards with particular emphasis on item 11deliverables. Knowledge of CDISC data structure requirements.
Extensive experience in SAS programming in aclinical data environment.
Extensive understanding of relational databasesand experience working with complex data systems.
Leadership experience, especially in the hiring,development, evaluation and support of junior staff and contractors.
Experience in the estimation of resourcerequirements.
Advanced degree in Statistics, Computer Science, Mathematics, Engineering, Life Science or related field.
Master degree and 7 years of programming experience preferably in processing clinical trial data in the pharmaceutical industry.
Job: Scientific Computing & Data Management
Primary Location: United States-New Jersey-Bridgewater
Job Posting: Sep 23, 2016, 12:12:56 PM
Job Type: Regular
Employee Status: Regular