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 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.
Lead statistical programming for clinical studies, ensuring high-quality CDISC-compliant deliverables and TLFs.
Provide hands-on SAS programming support for key analyses, ad hoc requests, and regulatory submissions.
Oversee CRO activities, mentor junior programmers, and drive departmental process improvements.
Immunome is a clinical-stage targeted oncology company developing first-in-class and best-in-class cancer therapies. The company offers an innovative, collaborative environment where employees are empowered to do their best work.
Deliver accurate, high-quality statistical programming outputs across the clinical trial lifecycle.
Develop and validate SDTM/ADaM datasets, tables, listings, and figures in accordance with CDISC standards.
Support regulatory submissions and collaborate with cross-functional teams to ensure data integrity and compliance.
A partner biotechnology company advancing innovative therapies through clinical development. They foster a collaborative, quality-focused environment with cross-functional teams and external partners.
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 for oncology clinical development programs, including Phase I–III trials and regulatory submissions.
Lead development of SAPs, sample size calculations, randomization strategies, and ensure quality of statistical deliverables.
Collaborate with cross-functional teams, serve as statistical SME, and mentor junior biostatisticians.
ClinChoice is a global full-service CRO delivering clinical development and functional solutions for pharmaceutical, biotechnology, and medical device companies. With over 4,000 professionals in 20+ countries, we are committed to high-quality delivery, continuous training, and a diverse, inclusive culture.
Lead biostatistics function for oncology clinical trials, including study design and statistical analysis.
Partner with clinical and regulatory teams to author key documents and ensure data quality.
Represent biostatistics in interactions with CROs and regulatory agencies to ensure project success.
Summit Therapeutics Inc. is a biopharmaceutical oncology company focused on improving quality of life. They have multiple global Phase 3 clinical studies and a team of world-class professionals driven by core values of integrity, passion, and collaboration.
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.
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.
Provide strategic statistical leadership across oncology development programs, collaborating with Clinical Development, Regulatory, Medical, Commercial, and Portfolio teams.
Design and validate trial types, endpoints, and innovative adaptive designs while performing sample size/power calculations and establishing go/no-go decision gates.
Support regulatory submissions and health authority interactions, and quantify technical success probability for pipeline prioritization.
We are 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 are committed to training, diversity, and accelerating innovative drug and device development.
Lead data management activities from study start-up to database lock, ensuring quality and timelines.
Act as subject matter expert for DM in sponsor meetings and implement process improvements.
Mentor and train junior DM staff while managing project documentation, data validation, and system setup.
Fortrea is a global contract research organization providing clinical development and biometrics services to pharmaceutical and biotechnology companies. With a focus on teamwork and excellence, they foster a family-like culture where employees collaborate to advance life-saving therapies.
Lead biostatistics efforts for analytical validation studies of molecular diagnostic tests.
Perform statistical analyses including sample size, power, agreement, precision, and LoD calculations.
Communicate complex statistical concepts to cross-functional teams and author study documentation.
Natera is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health. The team consists of highly dedicated professionals from world-class institutions who care deeply for their work and each other.