Lead end-to-end data management activities across clinical studies and development programs, ensuring clinical data is accurate, complete, reliable, and inspection-ready throughout the study lifecycle.
Compensation
Anticipated annual salary range of $145,000–$160,000, depending on experience, qualifications, internal equity, and location.
Annual bonus eligibility.
Significant equity opportunities.
Responsibilities
Oversee clinical data management strategy and execution for assigned studies
Serve as the lead Clinical Data Manager and primary Data Management contact for assigned studies
Lead core data management processes, including EDC database development, eCRF design, edit check specifications, user acceptance testing, Data Management Plans, database changes, data cleaning, external data reconciliation, and database lock activities
Oversee Data Management deliverables across assigned programs and provide expert guidance on the setup, configuration review, and user acceptance testing of Randomization and Trial Supply Management (RTSM) systems
Translate clinical protocol requirements into fit-for-purpose electronic Case Report Forms (eCRFs), data collection processes, and study-specific data review tools
Requirements
Bachelor's degree
Nice to have: Scientific or healthcare-related degree
The Manager of Statistical Programming Operations is responsible for optimizing and deploying business processes and technology solutions primarily focused on Artificial Intelligence adoption within DSS in support of the AbbVie portfolio.
Responsibilities
Lead/Support the design and implementation of cross-functional solutions, business processes, associated technologies and end-to-end agentic AI solutions tailored for specific pharma use cases
Partner with senior stakeholders across the enterprise to identify business needs, translate them into opportunities, and manage project delivery
Engage with multi-disciplinary experts to influence, elicit, analyze and document business requirements and translate into technology functional requirements
Develop and maintain automation scripts, workflows, and tools using programming languages and AI frameworks, ensuring secure, scalable, and compliant solutions
Deliver optimization of end-to-end business processes that enable quality and efficiency such as process maps, standard operating procedures, job aids, and work instructions
The Manager of Statistical Programming Operations is responsible for optimizing and deploying business processes and technology solutions primarily focused on Artificial Intelligence adoption within DSS in support of the AbbVie portfolio.
Responsibilities
Lead/Support the design and implementation of cross-functional solutions, business processes, associated technologies and end-to-end agentic AI solutions tailored for specific pharma use cases
Partner with senior stakeholders across the enterprise to identify business needs, translate them into opportunities, and manage project delivery
Engage with multi-disciplinary experts to influence, elicit, analyze and document business requirements and translate into technology functional requirements
Develop and maintain automation scripts, workflows, and tools using programming languages and AI frameworks, ensuring secure, scalable, and compliant solutions
Deliver optimization of end-to-end business processes that enable quality and efficiency such as process maps, standard operating procedures, job aids, and work instructions
The Manager of Statistical Programming Operations is responsible for optimizing and deploying business processes and technology solutions primarily focused on Artificial Intelligence adoption within DSS in support of the AbbVie portfolio.
Responsibilities
Lead/Support the design and implementation of cross-functional solutions, business processes, associated technologies and end-to-end agentic AI solutions tailored for specific pharma use cases
Partner with senior stakeholders across the enterprise to identify business needs, translate them into opportunities, and manage project delivery
Engage with multi-disciplinary experts to influence, elicit, analyze and document business requirements and translate into technology functional requirements
Develop and maintain automation scripts, workflows, and tools using programming languages and AI frameworks, ensuring secure, scalable, and compliant solutions
Deliver optimization of end-to-end business processes that enable quality and efficiency such as process maps, standard operating procedures, job aids, and work instructions
The Manager of Statistical Programming Operations is responsible for optimizing and deploying business processes and technology solutions primarily focused on Artificial Intelligence adoption within DSS in support of the AbbVie portfolio.
Responsibilities
Lead/Support the design and implementation of cross-functional solutions, business processes, associated technologies and end-to-end agentic AI solutions tailored for specific pharma use cases
Partner with senior stakeholders across the enterprise to identify business needs, translate them into opportunities, and manage project delivery
Engage with multi-disciplinary experts to influence, elicit, analyze and document business requirements and translate into technology functional requirements
Develop and maintain automation scripts, workflows, and tools using programming languages and AI frameworks, ensuring secure, scalable, and compliant solutions
Deliver optimization of end-to-end business processes that enable quality and efficiency such as process maps, standard operating procedures, job aids, and work instructions
Requirements
MS in Statistics, Computer Science or a related field
BS in Statistics, Computer Science or a related field
This role provides strategic leadership and scientific rigour across early clinical development at Roche, focusing on the ophthalmology portfolio, involving the design and analysis of exploratory clinical studies.
Locations (2)
Basel, Basel-City, Switzerland
Welwyn, England, United Kingdom
Responsibilities
Contributing to protocol design
Developing statistical analysis plans
Analysing complex, often high-dimensional data to inform early go/no-go decisions
Championing the use of innovative methodologies (e.g., adaptive, Bayesian designs)
Mentoring junior colleagues
Requirements
PhD or MSc in Statistics, Biostatistics, or a closely related quantitative field
Nice to have: Ophthalmology clinical trial experience
Nice to have: Early-phase experience across other therapeutic areas
Senior Data Integration Analyst responsible for integrating clinical trial data into the organization’s data hub, ensuring compliance with GCP and regulatory standards.
Responsibilities
Implement data flows and data mapping to meet clinical data hub standards
Coordinate study data integration activities with external providers and internal stakeholders
Liaise with internal customers and external providers to coordinate clinical data integration
Proactively anticipate and address data integration issues during study conduct
Identify areas for continuous improvement and participate
Requirements
Bachelor or Master of Science degree in life science, mathematics, computer science or related field
Statistical programmers work collaboratively with internal colleagues and external vendors to ensure the efficient, high-quality production of analysis datasets and statistical outputs for study reports and integrated summaries in support of Gilead’s regulatory, scientific and business objectives.
Locations (2)
Foster City, California, United States
Raleigh, North Carolina, United States
Compensation
Bay Area: $169,320.00 - $219,120.00.
Raleigh: $146,200.00 - $189,200.00.
Responsibilities
Works collaboratively with Clinical Development staff to meet project deliverables and timelines for statistical data analysis and reporting
Generates or oversees the production of programming deliverables (e.g., tables, figures, listings) for study reports and integrated summaries
Anticipates resource needs
Directs the design and/or coding of analysis files
Ensures programming and corresponding documentation is completed in a manner that is consistent with departmental procedures
Provide end‑to‑end statistical programming support across clinical development programs, leading and performing development and validation of SDTM, ADaM, and TLF datasets, ensuring compliance with CDISC standards and regulatory requirements.
Compensation
The potential base pay range for this role, when annualized, is $98,200.00 - $273,200.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.
Responsibilities
Provide end‑to‑end statistical programming support for clinical studies from study setup through submission
Lead and perform development and validation of SDTM datasets
Lead and perform development and validation of ADaM datasets
Lead and perform development and validation of Tables, Listings, and Figures (TLFs)
Ensure all deliverables are compliant with CDISC standards and regulatory requirements
Lead enterprise data governance and data management across NewAmsterdam Pharma’s cloud data platform, establishing standards, policies, and controls to ensure data integrity and regulatory compliance.
Locations (2)
United States
Philadelphia, Pennsylvania, United States
Compensation
We offer a competitive base salary, annual bonus, and long-term incentives.
Responsibilities
Build and run the enterprise data governance and data management function
Develop strategy, policy, and operating processes
Co-chair the Data Governance Council
Establish cross-functional accountability
Design data quality program and domain scorecards
Requirements
Nice to have: designing GxP readiness into a platform
Nice to have: maintaining a validated system in a cloud
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