Statistical Programming Lead- Manager (Analysis Oversight)

The Analysis Oversight Statistical Programming (AOSP) Lead is essential to these partnerships. As a member of the Study Management Team (SMT), the AOSP Lead works closely with the study team to determine the statistical programming requirements, understand study milestones and programming dependencies, and leads the development of the programming outputs.

The Analysis Oversight Statistical Programming Lead is accountable for the development of Analysis Data Model (ADaM) and Table, Figure, and Listing (TFL) deliverables, ensuring completeness, accuracy, and compliance with regulatory and quality standards.

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.
• Participates in internal and external audits and identifies areas of opportunity to refine and simplify procedural steps.
• 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.
• Assigns tasks to statistical programmers based on experience and ability.
• Closely monitors and tracks study statistical programming activities within task management system.
• Maintains regular communications on study statistical programming milestone activities with appropriate study team members and stakeholders.
• Influences and supports data and submission standards, templates, etc.
• Performs quality checks to ensure deliverables are complete, accurate, and comply with Gilead and CDISC standards.
• Ensures programming activities are executed in correct order.
• Ensures validation documentation, folder locking, and TMF requirements are observed.
• Surfaces the need for new or updated standards to improve efficiency and uniformity across TA or Indication level objects.
• Provides prioritization decisions and coaching to fellow onboarding staff as needed to advance their knowledge on Gilead processes and statistical programs & methods.
• Ensures the programming team identifies data issues and enters accordingly into the Data Issue Log.
• Holds analysis team meetings with Biostatisticians.
• 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

• Minimum 2 years leading studies in Virology, Oncology, or Inflammation Therapeutic Area
• 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.
• Remains current and has deep 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.
• Superior skills in coaching and mentoring staff of varying skillsets and respectful of cultural differences especially communication styles.
• Results-oriented and able to work closely with others through great collaboration to resolve challenges, bottlenecks, or risks.
• Ability to motivate large diverse teams to achieve a common set of goals.
• Strong experience in data analysis and demonstrated critical thinking skills.
• Strong programming experience in non-compartmental Pharmacokinetics (PK) analysis for various study designs.
• Oversee and guide the development of statistical programs for TQT, cQT, pharmacokinetics (PK), and pharmacodynamics (PD) analysis, ensuring adherence to study protocols and regulatory submissions.
• Able to lead and mentor effective cross functional teams and keep programming team promptly informed of all study activities.