Programming Project Leader

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 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 and teamwork in global interdisciplinary teams
Ability and mindset to embrace change, innovate and continuously improve programming practice

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

No preferred qualifications provided.