Programming Project Leader
- 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
- 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
- Bring the miracles of science to life alongside a supportive, future-focused team.
- Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
- Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
- 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.
#LI-SA #LI-Onsite
#vhd All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
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