Analysis Oversight Statistical Programming Lead- Manager

Key Responsibilities

• Exhibits strong statistical & programming knowledge & expertise to influence key decisions on statistical programming outputs and provide guidance to statistical programmers.
• Attends SMT Meetings, providing functional input on programming related activities and potential risks.
• Reviews and approves statistical programming requirements (e.g. ADaM Mapping Specifications).
• Communicates SMT decisions, discussions, and action items to statistical programmers.
• Reviews and approves key study documents.
• Helps statistical programmers understand critical study documents.
• Reviews statistical programming timelines and negotiates with study team if needed.
• Analyse vendor performance through assessment of Key Performance and Quality Indicators (e.g. KPI, KQI), metrics, and results.
• Participates as needed in vendor governance discussions to address any performance related risks and/or concerns.
• Ensures adequate statistical programming resourcing for study milestones.
• Serves as the point-of-contact with vendors, and liaisons with other functions.
• Requests the locking and archiving of study folders.

Minimum Required Education And Years Of Experience

• Bachelor's Degree and Seven Years’ Experience OR Masters' Degree and Five Years’ Experience

Preferred Qualifications

• Bachelor's Degree and Seven Years’ Experience OR Masters' Degree and Five Years’ Experience
• Mature statistical knowledge and expertise in the development of ADaM and TFLs and dependent tasks/activities.
• Proven track record in delivering high quality statistical programming datasets and outputs.
• Ability to collaborate and work effectively with global team members and build strong relationships.
• Expertise working in global teams, across various time-zones to achieve clinical trial milestones.
• Mature knowledge of GCP, ICH guidelines, and regulatory requirements, specifically as it relates to quality oversight, quality assurance, and risk management.
• Ability to problem-solve using data-driven approaches to help determine the best path forward.
• Excellent customer-focus with proven track-record in building relationships through superlative communication and writing skills.
• Strong experience in data analysis and demonstrated critical thinking skills.
• Strong programming experience in non-compartmental Pharmacokinetics (PK) analysis for various study designs.
• Able to lead and mentor effective cross functional teams and keep programming team promptly informed of all study activities.