Statistical Programming Lead- Manager (Analysis Oversight)

Gilead Sciences•Foster City, CA

About The Position

The Analysis Oversight Statistical Programming (AOSP) Lead is part of Clinical Data Science (CDS) within Development and is a member of the Study Management Team (SMT). The role partners closely with study teams to determine statistical programming requirements, understand study milestones and dependencies, and lead development of programming outputs. The AOSP Lead is accountable for Analysis Data Model (ADaM) and Table, Figure, and Listing (TFL) deliverables, ensuring they are complete, accurate, timely, and compliant with regulatory, quality, Gilead, and CDISC standards. The position monitors vendor performance through metrics and governance discussions, manages programming resources and deliverable priorities, performs quality oversight, and addresses study risks, challenges, and bottlenecks. It provides statistical and process guidance, mentors programming colleagues, and helps maintain onboarding materials. The role also supports data and submission standards, oversees documentation and study-folder requirements, and coordinates with biostatisticians, vendors, and other functions to support clinical trial milestones and regulatory submissions.

Requirements

Bachelor’s degree and seven years of experience, or a master’s degree and five years of experience.
At least two years leading studies in Virology, Oncology, or Inflammation therapeutic areas.
Mature statistical knowledge and expertise in developing ADaM datasets and TFLs and managing dependent tasks and activities.
Demonstrated record of delivering high-quality statistical programming datasets and outputs.
Ability to collaborate effectively with global team members and build strong relationships across time zones.
Current, in-depth knowledge of GCP, ICH guidelines, and regulatory requirements, particularly regarding quality oversight, quality assurance, and risk management.
Ability to solve problems using data-driven approaches.
Excellent customer focus and communication and writing skills, with a record of building relationships.
Strong coaching and mentoring skills across varying skillsets and respect for cultural differences, particularly in communication styles.
Results-oriented collaboration skills to resolve challenges, bottlenecks, and risks.
Ability to motivate large, diverse teams toward shared goals.
Strong data-analysis experience and demonstrated critical-thinking skills.
Strong programming experience in non-compartmental pharmacokinetic analysis across various study designs.
Ability to lead and mentor cross-functional teams and keep programming teams promptly informed of study activities.

Responsibilities

Provide statistical and programming expertise to guide decisions on statistical programming outputs and advise statistical programmers.
Attend Study Management Team meetings, provide programming-related input, and communicate decisions, discussions, and action items to statistical programmers.
Review and approve statistical programming requirements, including ADaM mapping specifications, and key study documents; help programmers understand critical study documentation.
Review programming timelines and negotiate them with the study team when needed.
Participate in internal and external audits and identify opportunities to refine or simplify procedures.
Assess vendor performance using Key Performance Indicators, Key Quality Indicators, metrics, and results; participate in vendor governance discussions to address performance risks and concerns.
Ensure adequate statistical programming resources for study milestones and assign tasks based on programmers’ experience and ability.
Monitor and track study programming activities in the task management system, and communicate milestone progress to study-team members and stakeholders.
Influence and support data and submission standards, templates, and related materials.
Perform quality checks to ensure deliverables are complete, accurate, and compliant with Gilead and CDISC standards.
Ensure programming activities occur in the correct order and that validation documentation, folder locking, and Trial Master File requirements are observed.
Identify needs for new or updated standards to improve efficiency and consistency across therapeutic-area or indication-level objects.
Make prioritization decisions and coach onboarding staff on Gilead processes, statistical programs, and methods.
Ensure the programming team identifies data issues, records them in the Data Issue Log, and resolves logged issues and observations before final production release.
Hold analysis-team meetings with biostatisticians.
Serve as the point of contact with vendors and liaise with other functions.
Request study-folder locking and archiving.
Oversee and guide development of statistical programs for TQT, cQT, pharmacokinetic (PK), and pharmacodynamic (PD) analyses, ensuring alignment with study protocols and regulatory submissions.
Lead and mentor cross-functional teams and keep programming teams informed of study activities.