Performs statistical programming and analysis of clinical trial data to support study reports and regulatory submissions.
Collaborates with CROs to validate statistical outputs, ensure accuracy, and resolve data analysis issues.
Develops and maintains SAS macros and safety databases while providing statistical input for SAPs and publications.
Immunovant is a clinical-stage biopharmaceutical company developing FcRn inhibitor therapies for autoimmune diseases. It operates in a dynamic, interactive, fast-paced, and entrepreneurial environment.
Lead statistical programming activities for clinical trials, collaborating with statisticians and data management teams.
Design, create, and validate SDTM and ADaM datasets, ensuring traceability and CDISC compliance.
Develop and validate Tables, Listings, and Figures using SAS for clinical study reports and regulatory submissions.
Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients suffering from autoimmune diseases. Guided by core values of collaboration and innovation, the company is committed to transforming the future of treatment for autoimmune disease.
Develop SAS programs to create clinical trial datasets and outputs.
Ensure compliance with CDISC, FDA, and regulatory standards.
Collaborate with biostatisticians and data managers to support trial reporting.
Penumbra is a global healthcare company focused on innovative therapies for challenging medical conditions. Its collaborative environment emphasizes continuous learning and rewards performance.
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.
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. They have over 4,000 professionals in more than 20 countries and a culture focused on quality, professional development, and supportive culture.
Lead statistical programming activities for Gene Therapy clinical trials from start-up through database lock, analysis, and reporting.
Develop, review, and validate SAS programs for SDTM, ADaM, Tables, Listings, and Figures in compliance with CDISC standards.
Collaborate with Biostatisticians and cross-functional teams to support regulatory submissions and manage study-level deliverables.
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. With over 4,000 professionals in more than 20 countries, we offer a supportive culture, continuous training, and a strong commitment to diversity and inclusivity.
Lead biostatistical activities for oncology clinical development programs, including study design and analysis strategies.
Collaborate with clinical development, regulatory, and programming teams to ensure high-quality evidence for submissions.
Apply advanced statistical methods, including Bayesian approaches, to support robust trial design and decision-making.
They are a biotechnology company developing innovative cancer therapies, including radiopharmaceutical treatments. The culture emphasizes scientific rigor, collaboration, and meaningful impact in a highly regulated environment.
Support statistical analyses of oncology endpoints, including time-to-event and response-based endpoints.
Review SDTM and ADaM specifications, statistical analysis plans, and study documentation while validating statistical outputs.
Collaborate with study teams to conduct routine data review and ensure quality and reproducibility of statistical deliverables.
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. With over 4,000 professionals in more than 20 countries, the company fosters a quality-driven 'one-team' culture that values continuous training and has below industry average turnover rates.
Provide statistical support across all phases of clinical development, including protocol design, analysis plans, and complex study methodologies.
Author and review statistical analysis plans, generate analysis datasets, tables, and figures using SAS, and perform quality control for statistical programs.
Act as a biostatistical consultant to sponsors and internal teams, overseeing study timelines, budgets, and regulatory interactions.
Precision Medicine Group is a precision medicine company providing comprehensive clinical development and biostatistics services. They are a global, equal opportunity employer with a collaborative and service-oriented culture.
Provide statistical leadership across clinical development programs from early-phase through late-phase trials.
Lead clinical trial design, develop SAPs, and oversee statistical analyses for regulatory submissions.
Collaborate with cross-functional teams and mentor statisticians to ensure scientific rigor and regulatory compliance.
ClinChoice is a global full-service CRO providing clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. With over 4,000 professionals in more than 20 countries, it fosters a quality-driven 'one-team' culture focused on continuous training and diversity.
Lead statistical programming deliverables (ADS and TLF) for clinical trials, ensuring regulatory compliance with ICH, GCP, and FDA 21 CFR Part 11.
Manage and develop a team of statistical programmers while contributing hands-on to programming work and maintaining R package infrastructure.
Collaborate cross-functionally with Biostats, Data Management, and Clinical Science to support regulatory submissions and develop R Shiny dashboards.
Natera is a global leader in cell-free DNA testing, dedicated to oncology, women's health, and organ health. The company consists of highly dedicated professionals from world-class institutions, committed to making personalized genetic testing part of standard care.
Manage all aspects of clinical trial data management from study start-up to post-database lock under supervision.
Oversee database development, testing, and quality control, ensuring compliance with SOPs and regulatory guidelines.
Coordinate with stakeholders, vendors, and sponsors to ensure timely and accurate data deliverables.
Precision for Medicine specializes in clinical data management and research services for drug and device development. The company values accuracy, teamwork, and adherence to regulatory standards.
Lead end-to-end clinical trial operations, ensuring compliance with GCP and regulatory standards.
Manage study start-up, regulatory submissions, TMFs, budgets, and cross-functional collaborations.
Drive risk mitigation and continuous improvement across clinical development programs.
This company is a clinical development organization focused on delivering high-quality clinical trials and advancing patient care. Its collaborative team of motivated professionals works remotely across the US with a strong emphasis on innovation and continuous improvement.