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.
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.
Knowledge and Skills:
Excellent technical skills in statistical programming, with advanced knowledge in SAS, 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:
A candidate with a Bachelor or Master of Science degree or equivalent in Statistics, Computer Science, Mathematics, Engineering, Life Science or related field, preferred.
A candidate with a Master degree and 5+ years of programming experience preferably in processing clinical trial data in the pharmaceutical industry.
A candidate with Bachelor degree and 7+ years of programming experience preferably in processing clinical trial data in the pharmaceutical industry.
Knowledge And Skills Desirable But Not Essential:
Experience with other operating systems and packages such as UNIX, MS Office.
Experience with other Statistical and Graphics software packages such as R, SPLUS, JMP.
Experience with an Electronic Data Capture (EDC), such as RAVE, Oracle Clinical.
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