Programing Project Leader

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 pharmac