Provide statistical support for assigned clinical studies under the guidance of the Biometrics/Biostatistics Team Lead or other senior statistical leadership.
Compensation
Target Base Pay Range: $116,000.00 - $151,000.00
Responsibilities
Provide statistical support for assigned clinical studies under the guidance of the Biometrics/Biostatistics Team Lead or other senior statistical leadership.
Collaborate with clinical, data management, statistical programming, and other cross-functional team members to support study activities.
Contribute statistical input to study design, protocol development, endpoint definition, and analysis planning.
Prepare and review assigned statistical analysis plans, case report forms, clinical database specifications, validation plans, table, figure, and listing shells, analysis dataset specifications, and related documentation.
Perform statistical analyses, simulations, and ad hoc analyses as needed.
Requirements
Master's degree in Statistics, Biostatistics, or related field
Ph.D. preferred
Nice to have: R or other statistical software
Nice to have: experience with external vendors or contract research organizations
A senior-level contributor responsible for designing, developing, validating, and maintaining statistical programming deliverables to support clinical trials and regulatory submissions.
Responsibilities
Lead the development, validation, and maintenance of SDTM and ADaM datasets and associated documentation.
Program complex Tables, Listings, and Figures (TLFs) for study reports, publications, and submissions.
Review and interpret statistical analysis plans (SAPs) to ensure accurate implementation in code.
Serve as lead programmer on multiple studies and/or projects, coordinating efforts across internal teams and CROs.
Provide technical oversight and mentoring to junior programmers and contractors.
Requirements
Bachelor's Degree
Master's degree in Computer Science, Statistics, Mathematics, Life Sciences, or related field
Lead and manage statistical programming projects for clinical studies, ensuring quality deliverables and process improvement.
Compensation
The annual base salary range for the Senior Manager, Statistical Programming is from :$138,800-$182,200. Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan.
Responsibilities
Manage statistical programming projects
Develop and review SAS code and datasets
Create summary tables, graphs, and listings
Review statistical analysis plans
Collaborate with Biostatistics, Data Management, Clinical Ops
Oversee clinical data management activities across assigned clinical trials, including database development, data collection, cleaning, validation, and query resolution.
Compensation
Pay Rate: $40-$55/hr
Responsibilities
Oversee clinical data collection, cleaning, validation, and quality review across assigned clinical trials.
Support the design, development, and testing of clinical databases and EDC systems, including User Acceptance Testing (UAT).
Manage data queries, reconciliation, and resolution in collaboration with clinical sites and CRO partners.
Develop and maintain Python scripts to automate data extraction, validation, cleaning, and reporting.
Identify workflow inefficiencies and implement technical solutions to improve data accuracy and operational efficiency.
Requirements
Bachelor's degree in Life Sciences, Computer Science, Health Informatics, Data Science, or a related field.
Lead and oversee statistical programming activities for oncology clinical trials, providing expertise and leadership in support of clinical development programs.
Responsibilities
Lead and oversee statistical programming activities for oncology clinical trials
Develop, validate, and maintain SDTM and ADaM datasets in compliance with CDISC standards
Program and review complex TFLs for clinical study reports and regulatory submissions
Support oncology efficacy and safety analyses
Demonstrate expertise in Kaplan-Meier analysis, Cox proportional hazards models, and other time-to-event analyses
Requirements
Bachelor's or Master's degree in Statistics, Biostatistics, Mathematics, Computer Science, or a related discipline
Nice to have: Immuno-oncology
Nice to have: Targeted cancer therapies
Nice to have: Head and neck, lung, colorectal, breast solid tumor indications
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
Oversee end‑to‑end data collection and validation processes, design robust clinical databases, and maintain compliance across all clinical trials.
Responsibilities
Oversee data collection, cleaning, and validation activities across assigned clinical trials to ensure high data quality, accuracy, and completeness.
Participate in the design, development, and testing of Electronic Data Capture (EDC) systems, user acceptance testing (UAT), and data validation specifications.
Manage query generation, reconciliation, and resolution workflows, working closely with clinical trial sites and CRO partners.
Develop and execute custom Python scripts and software utilities to automate data extraction, validation, routine cleaning checks, and metrics reporting.
Evaluate trial data infrastructure to identify technical bottlenecks, implementing software solutions that enhance processing speed and data accuracy.
Requirements
Bachelor’s Degree in Life Sciences, Computer Science, Health Informatics, Data Science, or a related field
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