Develop, validate, and maintain SDTM and ADaM datasets using R following CDISC standards for clinical trial data.
Collaborate with statisticians and data teams to understand requirements and ensure deliverables meet regulatory expectations such as FDA and EMA.
Write efficient, reproducible R scripts, support TLF generation, and contribute to programming workflows, documentation, and automation initiatives.
ClinChoice is a global contract research organization (CRO) that specializes in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. With over 4,000 professionals across more than 20 countries, it fosters a diverse and inclusive culture focused on employee development and low turnover through close management and continuous training.
Lead statistical programming activities across clinical programs, ensuring the development and quality control of tables, listings, figures, analysis datasets.
Oversee external functional service providers to ensure timely and high-quality programming deliverables.
Drive the adoption of innovative programming technologies and workflows to enhance the efficiency of clinical data review, cleaning, reconciliation, and integration.
Recursion is a clinical-stage TechBio company decoding biology to radically improve lives. The company is advancing a portfolio of differentiated investigational medicines across its wholly owned and partnered pipeline. Recursion's platform infrastructure is anchored in Salt Lake City, Utah and Milton Park, Oxfordshire.
Accountable for all core SP deliverables (SDTM, ADAM, TFLs).
With IT, defines our programming environment and its validation.
Responsible for the development of standards, SOPs, and best practices.
Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities. Mineralys is a fully remote company that appears to be mid-sized, offering a collaborative and fast-paced environment.
Collaborate with Data Management to support data cleaning, external data review, reconciliation, database lock, and data quality activities.
Braveheart Bio is a Bay Area–based biopharmaceutical company pioneering best-in-class therapies for cardiovascular disease. They have a proven leadership team, a strong financial foundation, and a high-value late-stage asset, making it an outstanding opportunity for mission-driven professionals.
Provide statistical support for Phase I–IV clinical trials.
Participate in protocol development, study design, and sample size calculations.
Prepare and review Statistical Analysis Plans (SAPs), TLF shells, and randomization specifications.
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 with a mission to contribute to a healthier and safer world.
Contribute to the design of early/late-stage protocols across multiple therapeutic areas.
Develop and write statistical analysis plans, and perform statistical analyses for interim and final reports.
Support submission activities, including design, analysis and reporting of integrated summaries for safety and efficacy.
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, they focus on quality, professional development, and a supportive culture.
Represent the Biostatistics function for complex studies or at project level.
Independently contribute to design of early/late-stage protocols across multiple therapeutic areas and help draft protocols or amendments.
Develop and write statistical analysis plans and perform statistical analyses for interim and final reports to be submitted to regulatory agencies.
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 across the Americas, Europe, and Asia-Pacific.