Programing Project Leader

Overview

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.

• 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.
• At the department level, 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.

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 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 UNIX and MS Office; experience with other statistical and graphics software packages such as R, SPLUS, JMP.
• Experience with Electronic Data Capture (EDC) systems such as RAVE, Oracle Clinical.

• Bring the miracles of science to life alongside a supportive,…