Job Title: Programing Project Leader
Location: Morristown, NJ
About the Job
Position Overview:
The incumbent is a programming project lead (PPL), responsible for all programming activities at the level of a project, i.e. all studies and submissions.
We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.
Main Responsibilities:
Provides and maintains project plan for all projects/studies including milestones, tasks, and coordination of programming activities.
Provides leadership and guidance to ensure high quality and timely statistical programming deliverables within a project, ensure technical validity, compliance to internal standards and SOPs, regulatory requirements.
Ensures standardization and consistency of documents and programming deliverables across studies (clinical study reports, CSR) and for integrated analyses (ISS/ISE).
Provides technical guidance and leadership to metadata specifications and project/study specific data requirements.
Plans and leads regulatory submission activities.
Supervises the quality controls (QC) methods and processes for programming deliverables in both study and submission level activities.
Participates in clinical project meetings and provide input, whenever relevant.
Identifies areas for improvements within a project and make suggestions for changes and implementation, as appropriate.
Acts as mentor to junior staff with regard to programming techniques, project management and implementation of standards.
Assists in the development, evaluation and support of junior staff and contractors.
Provides technical expertise and hands-on support to the programming team.
In addition, at the department level, the incumbent:
Leads/participates in working groups either within-department or as a department representative cross-function.
Supports department initiatives and task forces and contributes to department standards and processes.
About You
Knowledge and Skills:
Excellent technical skills in statistical programming, with advanced knowledge in SAS, R and other statistical computing software.
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. understanding of statistical concepts, techniques and clinical trial principles) and ability to manage and lead regulatory submissions.
Excellent understanding of internal SOPs and industry regulations.
Ability to act as the key contact for programming management, to anticipate activities, alert for potential issues and propose adequate solutions.
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, problem-solve and teamwork in global interdisciplinary teams.
Ability and mindset to embrace change and continuously improve programming practice.
Formal Education and Experience:
Bachelor or Master of Science degree or equivalent in Statistics, Computer Science, Mathematics, Engineering, Life Science or related field, preferred.
Master degree and 4+ years of programming experience preferably in processing clinical trial data in the pharmaceutical industry.
Bachelor degree and 6+ years of programming experience preferably in processing clinical trial data in the pharmaceutical industry.
PhD candidates will be considered
Knowledge and Skills Desirable but not essential:
Experience with other operating systems and packages such as UNIX, MS Office.
Experience with other Statistical and Graphics software packages such as R, SPLUS, JMP.
Experience with an Electronic Data Capture (EDC), such as RAVE, Oracle Clinical.
Why Choose Us?
Bring the miracles of science to life alongside a supportive, future-focused team.
Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.
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.
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Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!
US and Puerto Rico Residents Only
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; 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.
North America Applicants Only
The salary range for this position is:
$122.250,00 - $176.583,33All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.