Programming Project Leader

<p><span><b>Job Title:</b> Programming Project Leader</span></p><p><span><b>Location: </b>Morristown, NJ</span><br /> </p><p><b>About the Job</b></p><p><br /><u><span>Position Overview:</span></u><br /> </p><p><span>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.</span><br /> </p><p><span>We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing &amp; 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.</span></p><p><span> </span></p><p><u><b><span>Main Responsibilities:</span></b></u><br /> </p><ul><li><p><span>Provides and maintains project plan for all projects/studies including milestones, tasks, and coordination of programming activities.</span></p></li><li><p><span>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.</span></p></li><li><p><span>Ensures standardization and consistency of documents and programming deliverables across studies (clinical study reports, CSR) and for integrated analyses (ISS/ISE).</span></p></li><li><p><span>Provides technical guidance and leadership to metadata specifications and project/study specific data requirements.</span></p></li><li><p><span>Plans and leads regulatory submission activities.</span></p></li><li><p><span>Supervises the quality controls (QC) methods and processes for programming deliverables in both study and submission level activities.</span></p></li><li><p><span>Participates in clinical project meetings and provide input, whenever relevant.</span></p></li><li><p><span>Identifies areas for improvements within a project and make suggestions for changes and implementation, as appropriate.</span></p></li><li><p><span>Acts as mentor to junior staff with regard to programming techniques, project management and implementation of standards.</span></p></li><li><p><span>Assists in the development, evaluation and support of junior staff and contractors.</span></p></li><li><p><span>Provides technical expertise and hands-on support to the programming team.</span></p></li><li><p><span>In addition, at the department level, the incumbent:</span></p></li><li><p><span>Leads/participates in working groups either within-department or as a department representative cross-function.</span></p></li><li><p><span>Supports department initiatives and task forces and contributes to department standards and processes.</span></p></li></ul><p></p><p><b>About You</b></p><p><span> </span></p><p><u><span>Knowledge and Skills:</span></u></p><p></p><ul><li><p><span>Excellent technical skills in statistical programming, with advanced knowledge in SAS, R and other statistical computing software.</span></p></li><li><p><span>Ability to perform, coordinate and oversee the preparation, execution, reporting and documentation of all programming deliverables of a project, with minimal supervision.</span></p></li><li><p><span>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.</span></p></li><li><p><span>Excellent understanding of internal SOPs and industry regulations.</span></p></li><li><p><span>Ability to act as the key contact for programming management, to anticipate activities, alert for potential issues and propose adequate solutions.</span></p></li><li><p><span>Ability to collaborate with external partners (CROs, Partners, etc.) and manage outsourced activities.</span></p></li><li><p><span>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.</span></p></li><li><p><span>Strong skills that demonstrate initiative, motivation, problem-solve and teamwork in global interdisciplinary teams.</span></p></li><li><p><span>Ability and mindset to embrace change and continuously improve programming practice.</span></p></li></ul><p><span> </span></p><p><u><span>Formal Education and Experience:</span></u><br /> </p><ul><li><p><span>Bachelor or Master of Science degree or equivalent in Statistics, Computer Science, Mathematics, Engineering, Life Science or related field, preferred.</span></p></li><li><p><span>Master degree and 4&#43; years of programming experience preferably in processing clinical trial data in the pharmaceutical industry.</span></p></li><li><p><span>Bachelor degree and 6&#43; years of programming experience preferably in processing clinical trial data in the pharmaceutical industry.</span></p></li><li><p><span>PhD candidates will be considered</span></p></li></ul><p><span> </span></p><p><u><span>Knowledge and Skills Desirable but not essential:</span></u></p><p></p><ul><li><p><span>Experience with other operating systems and packages such as UNIX, MS Office.</span></p></li><li><p><span>Experience with other Statistical and Graphics software packages such as R, SPLUS, JMP.</span></p></li><li><p><span>Experience with an Electronic Data Capture (EDC), such as RAVE, Oracle Clinical.</span></p></li></ul><p></p><p><span><b>Why Choose Us?</b> </span></p><ul><li><p><span>Bring the miracles of science to life alongside a supportive, future-focused team. </span></p></li><li><p><span>Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally. </span></p></li><li><p><span>Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. </span></p></li><li><p><span>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. </span></p></li></ul><p><span> </span></p><p><span>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.</span><br /> </p><p><span><span>#GD-SA  </span><br /><span>#LI-SA</span></span></p><p><span><span>#vhd</span></span></p><p><span><span>#LI-Hybrid</span></span></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p><h1>Pursue <i>progress</i>, discover <i>extraordinary</i></h1><p>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.</p><p></p><p>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.</p><p></p><p>Watch our <a href="https://www.youtube.com/watch?v&#61;SkpDBZ-CJKw&amp;t&#61;67s" target="_blank">ALL IN video</a> and check out our Diversity Equity and Inclusion actions at <a href="https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness" target="_blank">sanofi.com</a>!</p><p></p><p></p><p><i>US and Puerto Rico Residents Only</i></p><p>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.</p><p></p><p><i>North America Applicants Only</i></p><p></p><p>The salary range for this position is:</p>$122.250,00 - $176.583,33<p></p><p>All 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 <a target="_blank" href="https://benefits.sanofiusallwell.com/fleet/public/index/ba511bf8-5c32-4828-9861-ab985fffab90/?cid&#61;sanofi">LINK</a>.</p>