Programming Project Leader

Job Title: Programming Project Leader 

Location: Morristown, NJ

About the Job

Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress. 

Lead one or more statistical programming project team(s). Responsible for all programming activities at the project/indication level.  Contribute to department initiatives and task forces.

Programming Project Lead (PPL) of a moderate size project / one or several indications of a project in late phase clinical development.  With limited direction from group manager, plan and execute statistical programming activities for responsible project(s) in Oncology and/or Neurology. 

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main Responsibilities:

• Provide leadership, guidance and hands-on support to ensure high quality and timely statistical programming deliverables within a project, ensure technical validity, compliance to internal standards and SOPs, regulatory requirements

• Plan and track programming project activities, timelines, and resource use in cross-site global setting; provide justification for planned resource needs, seek to optimize resource utilization thru efficient and well-managed resource allocation and across projects or areas

• Ensure standardization and consistency in specifications and programming deliverables across individual studies and for integrated analyses

• Provide technical guidance and leadership to metadata specifications and project/study specific data requirements

• Lead regulatory submission activities, including electronic submission packages

• Supervise the quality controls (QC) methods and processes for programming deliverables in both study and submission level activities

• Provide guidance to junior staff on programming techniques, project management and implementation of standards

• Collaborate effectively with project statistician and with other functions in the aligned project team; participate in clinical project meetings and provide inputs, whenever relevant

• Lead oversight activities for outsourcing engagements; guide team members to effectively interact with external resources

• Participate in departmental initiatives; provide inputs to programming standardization and process optimization

About You

Required Education/Experience:

• Bachelor or Master of Science degree or equivalent in Statistics, Computer Science, Mathematics, Engineering, Life Science or related field

• US: MS / BS with at least 5+ / 7+ years of programming experience preferably in processing clinical trial data in the pharmaceutical industry

• 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. statistical concepts, techniques and clinical trial principles) and ability to lead regulatory submissions

• Ability to collaborate with external partners (CROs, Partners, etc.) and manage outsourced activities

• Excellent verb