Job Description
Clinical Data Science (CDS) is a business unit within Development whose mission is to achieve regulatory approval and successful marketing of new therapies through a reproducible, transparent, efficient, and validated approach to study design, data acquisition, analysis, and interpretation. Our pursuit is to deliver on unmet medical needs by introducing therapies for life-threatening diseases. Within CDS, we strive to reach this goal through excellence in data management, analytical methods, and advanced programmatic approaches to gain insights from a wide range of data assets.To achieve the commitments of our clinical portfolio, CDS has been developing an agile and sustainable resource model that leverages external partnerships to form a strong alliance with internal Gilead roles. Together, these teams will deliver statistical programming outputs that meet study analysis needs and requirements. 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. This role will progressively review vendor performance metrics in governance meetings to monitor trends and address any challenges, risks, and/or bottlenecks encountered by the study programming team.The position requires a strong acumen in statistical analysis, focused on achieving high-quality outputs that support clinical results. In addition, the candidate will need to perform quality management, coach and mentor programming colleagues, and provide statistical guidance as it relates to specifics of the study and general processes and statistical program education. The candidate will need to closely monitor the quality and timeliness of clinical trial programming deliverables, provide process guidance, support creation and maintenance of onboarding materials, and direct prioritization and coordination of study related deliverables.
Key Responsibilities will include, but are not limited to the following:
- 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. In addition, ensures all issues and observations noted on the issue log have been resolved prior to final production release.
- 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:
- Bachelor's Degree and Seven Years’ Experience OR
Masters' Degree and Five Years’ Experience - 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.
People Leader Accountabilities
- Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.
- Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.
- Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.
