Provide focused attention on critical planning by driving the efficient execution of deliverables involving Clinical Statistics, Clinical Programming and Medical Writing activities
Drive cross-functional communication and engagement with internal and external stakeholders
Develop, gain alignment, and implement project plans (e.g. activities, deliverables, timelines, resources, work assignments) that are aligned with the R&D approved objectives and timelines with input from GSD Functional Lead(s)
Track progress against scheduled milestones and activities, collect metrics data, and proactively identify operational risks/issues and provide input on remediation plans
Ensure GSD project team is compliant with regulatory requirements and guidance, corporate and departmental procedures, and standards. Identify potential compliance issues within GSD project team (e.g. knowledge gaps) and partners with functional management to remediate
Provide input and support GSD study and project timeline template updates
Serves as an expert within own function ; Trains and mentors junior staff
Support, contribute to, and lead internal BSO initiatives
Your experience and qualifications
Master or PhD in statistics, data science, computer science, life sciences or other related fields
Minimum of 5 years of relevant CRO/pharmaceutical experience of managing projects related to Biometrics deliverables and regulatory activities