Associate Director, Analysis & Reporting

Associate Director, Analysis & Reporting
United States – RemoteUnited States - New Jersey - Morris PlainsUnited States - California - Foster CityUnited States - Washington - Seattle

Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

Making an impact on a global scale
Inclusion is one of the company’s five core values. That’s because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.

When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

At Gilead we believe every employee deserves a great leader. As a people leader now or in the future, we expect that you will model and create an environment of inclusion, be intentionally focused on the hiring, development, growth and retention of talent, and empower teams to align and achieve goals.
Job Description


The Associate Director of Analysis Planning and Reporting Standards is responsible for collaborating with Biostatistics to drive the standards and governance of the Gilead clinical data standards related to analysis planning. This role drives the standards and governance related to analysis reporting. This role provides leadership for the continued development and enforcement of data standards, with focus on analysis planning and reporting standards - which includes the statistical analysis plan template, tables, figures, and listings mockups and requirements -- and collaborates extensively with Biostatistics, Medical Writing, and Clinical Development, as well as various cross-functional groups where needed. In Collaboration with the Data Collection Standards, Data Acquisition Standards, SDTM Standards, and ADaM Standards individuals, this role works to implement data standards after an extensive upstream/downstream impact is assessed, maintaining consistency with the other data standard states to ensure accurate and seamless use of end-to-end data standards.

Through a strong understanding of end-to-end standards and data flows, this role will support study teams in thinking about analysis early-on in trial design to ensure dependent upstream tasks accommodate analysis & reporting requirements.

Responsibilities

• Collaborates with Biostatistics, Statistical Programming, Medical Writing, Clinical Development, and other cross-functional study team members where needed to identify new solutions in analysis planning and reporting that support the scientific need of a study/program and ensure alignment with the analysis planning and reporting strategy.
• Collaborates extensively with the Biostatistics Point of Contact on study team questions or requests for new standards related to analysis planning and reporting. Helps to facilitate discussions and decisions with the Biostatistics subject matter experts (SMEs) that are accurate and timely and can be implemented as analysis standards and reporting standards.
• Reviews, maintains, and curates new or updated analysis planning standards resulting from discussions with Biostatistics SMEs, as well as Medical Writing and Clinical Development, where needed. Implements, maintains, and curates the new or updated analysis reporting standards in consultation with the Biostatistics Point of Contact, as well as Biostatistics SMEs, Medical Writing, and Clinical Development, where needed.
• Regularly meets with CRF Standards, Data Acquisition Standards, SDTM Standards, and ADaM Standards subject matter experts to create holistic standard solutions for study/project teams while ensuring quality, consistency, and compliance to CDISC standards and industry standards for analyses. Implements future strategies and technology-enabled processes and/or tools for the Gilead analysis standards.
• Serve as a subject matter expert on Gilead's reporting standards and related tools/applications, such as STARS. Maintains requirements and documentations for these tools/applications. In-depth knowledge of clinical trial processes for analyses and governance.
• Responsible for supporting continuous improvements centered around consistency and standardization of analysis, such as Dose Escalation.
• Facilitates all reporting standards related future strategies and implementation, including but not limited to project management, timeline generation, and change control management. Leads a team of technical individuals. Collaborates with Data Engineering/Macros & conducts pilot testing.
• Creates quality control processes, metrics and other measures to ensure compliance with analysis planning and reporting standards.
• Creates any needed documentation and training related to analysis planning and reporting standard processes and tools.
• Assists the Director of Data Tabulation and Analysis in managing communications on standards updates to Stakeholders.
• Contributes in industry and professional forums discussing the creation of safety and other reporting standards.
• Supports data-driven analysis to influence study teams on impacts and benefits for following standardized objects.

Qualifications

• 10 Years of experience and a BS degree in Biostatistics/Statistics or equivalent.
• 8 Years of experience and a MS degree in Biostatistics/Statistics or equivalent.
• 2 Yeas of experience and a PhD in Biostatistics/Statistics.
• At least 10 years relevant experience in a pharmaceutical, biotech, CRO or Regulatory Agency. Experience in clinical data management and/or trial management experience with technical expertise in standards management and implementation preferred.
• Knowledge of analysis planning and reporting best practices and tools (such as a statistical analysis plan generator) and has a track record in applying own knowledge to significantly improve efficiencies.
• Demonstrated knowledge of clinical research, metadata management, industry standards (CDISC), FDA & ICH, GCP, and related regulatory requirements. Experience in implementing pharmaceutical industry standards such as CDISC, SDTM, ADaM, etc. Exhibits strong understanding of end-to-end standards and data flows in order to properly support analysis planning, and reporting.
• Demonstrated experience managing multiple tasks, complex projects and working with cross-functional teams delivering to project timelines and metrics.
• Demonstrated ability to establish effective business relationships with external stakeholders.
• Strong problem-solving, verbal and written communication skills; independent and effective working in a multi-disciplinary environment.
• Self-driven with a focus on delivering results and outcomes that the support the mission of Clinical Data Standards.
• Deep technical acumen of various programming languages and algorithmic models to produce a wide range of analytical and reporting deliverables.
• Ability to study and analyze different data types and volumes in order to build scalable solutions.
• Experience and knowledge in all phases of clinical trials.
• Display aptitude for creativity and innovation.
• Project management, organizational and self-management skills with a focus on results for timeline and accurate completion of competing deliverables
• Self-motivated to identify and resolve problems with a keen eye on details
• Proven ability to collaborate in a global environment with colleagues and functional partners across time zones.
• Demonstrated negotiation skills to reconcile differing viewpoints and opinions into actionable decisions.
• Thorough understanding of worldwide patient privacy regulations and guidance.

For Colorado Job Applicants: The salary range for this position is:
$159,040.00 - $238,560.00
Gilead considers a range of factors, including background and experience, when determining base compensation. These considerations means actual compensation will vary.
Position is also eligible for bonus and benefits. For more information, visit https://www.gilead.com/careers/compensation-benefits-and-wellbeing

For jobs in the United States:

As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact careers@gilead.com for assistance.

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