Analysis Oversight Statistical Programming Lead- Manager

Key Responsibilities: Provide strong statistical & programming expertise to influence decisions on statistical programming outputs and guide statistical programmers. Attend Study Management Team (SMT) meetings; provide functional input on programming activities and potential risks. Review and approve statistical programming requirements (e.g., ADaM Mapping Specifications). Communicate SMT decisions, discussions, and action items to programmers. Review and approve key study documents; help programmers understand critical documents. Review programming timelines; negotiate with the study team as needed. Participate in internal/external audits; identify improvements to simplify procedural steps. Analyze vendor performance using KPIs/KQIs and participate in vendor governance as needed. Ensure adequate statistical programming resourcing for study milestones. Assign tasks to programmers based on experience/ability; track activities in task management systems. Maintain regular communications with study stakeholders on programming milestones. Support data/submission standards and templates. Perform quality checks to ensure deliverables are complete/accurate and comply with Gilead and CDISC standards (including correct execution order, validation documentation, folder locking, and TMF requirements). Surface needs for new/updated standards to improve efficiency/uniformity. Coach onboarding staff; oversee Data Issue Log entry and resolution prior to final production release. Hold analysis team meetings with biostatisticians. Serve as point-of-contact with vendors and liaise with other functions; request locking/archiving of study folders. Minimum Required Education & Experience: Bachelor’s degree + 7 years’ experience OR Master’s degree + 5 years’ experience. Preferred Qualifications: 2+ years leading studies in Virology, Oncology, or Inflammation. Mature expertise in ADaM and TFL development; proven delivery of high-quality statistical programming outputs. Knowledge of GCP, ICH, and regulatory requirements for quality oversight/assurance and risk management. Strong non-compartmental PK programming experience. Ability to oversee programs for TQT, cQT, PK, and PD while ensuring adherence to protocols and regulatory submissions. Strong global collaboration, coaching/mentoring, and cross-functional leadership. People Leader Accountabilities: Create Inclusion; Develop Talent; Empower Teams. Application instructions: Apply via the Internal Career Opportunities portal in Workday. Benefits: Eligible employees may participate in benefits plans (medical, dental, vision, and life insurance). #J-18808-Ljbffr Scorpion Therapeutics