Lead the definition, implementation and governance of Pierre Fabre's Clinical Data Standards Strategy, including the CDISC-based sponsor standards library.
Responsibilities
Lead the definition, implementation and governance of Pierre Fabre's Clinical Data Standards Strategy.
Own and evolve the Pierre Fabre Sponsor Standards Library built on top of CDISC standards.
Establish standards governance processes, lifecycle management, version control and change management practices.
Lead the development, maintenance and governance of standards covering eCRF libraries, SDTM, ADaM, edit checks, controlled terminology and study metadata.
Ensure Pierre Fabre standards remain aligned with evolving regulatory expectations and industry best practices.
Requirements
Master's Degree or PhD in life sciences, data management, statistics, programming or a related field
Developing and validating R programs for statistical analysis and reporting of clinical trial data.
Leading more than one Statistical Programming team to create, validate and generate statistical outputs, including listings, tables, figures, and CDISC-compliant SDTM and ADaM datasets.
Collaborating with biostatisticians to define analysis plans and statistical methods to be applied to clinical data.
Performing quality control and validation of statistical outputs, ensuring accuracy, consistency, and regulatory compliance.
Assisting in the preparation of statistical reports, presentations, and publications to support regulatory submissions and clinical study reporting.
Requirements
Bachelor's or Master's degree in Statistics, Mathematics, Computer Science, Life Sciences, or a related quantitative field.
Administrar los recursos humanos y materiales de su área para que se puedan satisfacer las necesidades del cliente, cumpliendo siempre con los requerimientos de Productividad, Calidad, Entrega y Seguridad.
Responsibilities
Administrar los recursos humanos y materiales de su área para que se puedan satisfacer las necesidades del cliente, cumpliendo siempre con los requerimientos de Productividad, Calidad, Entrega y Seguridad.
Administrar los recursos humanos y materiales del proceso productivo para cumplir con el programa de producción en tiempo y forma y como resultado cubrir los requerimientos del cliente.
Lograr los objetivos establecidos por la organización para garantizar la rentabilidad del negocio.
This role drives the statistical strategy and execution behind Denali's core clinical development programs, translating complex data into insights that inform therapeutic decisions for neurodegenerative disease programs.
Compensation
Salary Range: $155,000.00 to $202,000.00
Responsibilities
Leads development of key clinical study deliverables, including statistical analysis plans, protocol statistical sections, and clinical study reports.
Ensures statistical integrity and accuracy of analysis and reporting deliverables, meeting pre-specified requirements, internal SOPs, and external regulatory standards.
Conducts hands-on exploratory analyses, sample size estimation, and modeling/simulation; builds tools to extract insights from data.
Interprets and presents data and statistical considerations to internal project teams and senior management.
Oversees Biostatistics vendors and contract research organizations, providing quality oversight of in-house and external statistical deliverables.
Requirements
PhD in Statistics, Biostatistics, or a related discipline
Lead senior technical expert in statistical programming for clinical trial data, developing, validating, and delivering SAS deliverables in compliance with CDISC standards.
Compensation
$154,230—$177,726 USD
Responsibilities
Develop and validate CDISC-compliant datasets and reports
Provide SAS programming support for analyses and regulatory deliverables
Adhere to programming timelines and manage risks
Collaborate with Biostatistics, Data Management, Clinical Operations, and Safety teams
Review data management plans and specifications
Requirements
Master's degree in Statistics, Computer Science or related field
The Principal Stat Programmer plays a critical role in ensuring the accuracy and integrity of statistical programming across various clinical projects.
Responsibilities
Develops and validates complex datasets and outputs using SAS programming, ensuring compliance with CDISC standards such as ADaM and SDTM models.
Collaborates with cross-functional teams to optimize statistical programming processes and enhance overall efficiency and accuracy.
Provides technical guidance and expertise on statistical methodologies to support clinical trial projects and departments.
Mentors and guides junior programmers, fostering their growth and development.
Contributes to the continuous improvement of programming workflows and departmental standards.
Requirements
Bachelor's Degree in Statistics, Computer Science or related field
Lead and manage biostatistical programming activities for Amgen’s Biosimilar organization, coordinating with CROs and cross‑functional teams to develop datasets, analysis plans, and submission packages.
Compensation
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. Salary Range 151,838.05USD -205,427.95 USD
Responsibilities
Represent the product programming function and participate in multidisciplinary project team meetings
Collaborate closely with Biosimilar Statisticians and other functional team members
Coordinate and oversee the development of dataset specifications and implementation of TLGs according to the statistical analysis plans
Review and approve analysis dataset specifications
Review or contribute to data management plans, database development, and edit checks plan
Requirements
BA/BSc or higher degree in quantitative or scientific subjects
Nice to have: MSc or higher degree in quantitative or scientific subjects
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