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.
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.
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.
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.
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 and oversee statistical programming across Phase I–III oncology trials.
Manage, mentor, and guide statistical programmers; ensure SDTM/ADaM and TFL delivery.
Collaborate cross-functionally and ensure compliance with CDISC and regulatory guidelines.
ClinChoice is a global full-service CRO specializing in clinical development for pharmaceutical, biotech, and medical device companies. With over 4,000 professionals across 20+ countries, the company emphasizes quality, professional development, and a supportive culture built on diversity and inclusivity.
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.
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.
Provide strategic leadership and operational oversight for clinical trial design, analysis, and reporting.
Build and mentor a high-performing clinical biostatistics team while driving regulatory submissions.
Partner with cross-functional teams and vendors to ensure high-quality statistical and data management support.
Enveda is a clinical-stage, AI-enabled biotech discovering medicines from nature four times faster than industry standard. With over $845M in total funding and a $2B valuation, the company is recognized as a top startup employer and has three oral medicines in the clinic.
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.
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.
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.
Develops CMC regulatory strategies for biologics from early phase through marketing applications and post-approval changes.
Leads interactions with health authorities and oversees the preparation of regulatory submissions including INDs, BLAs, and MAAs.
Provides mentorship to regulatory CMC talent and ensures compliance with global regulations.
Summit Therapeutics Inc. is a biopharmaceutical oncology company focused on improving quality of life and resolving unmet medical needs. They have a global presence with multiple Phase 3 clinical studies and an employee-driven culture centered on integrity and passion for excellence.
Independently design and lead statistical disclosure control strategies for complex health datasets.
Serve as signing Expert Determiner applying statistical principles to ensure re-identification risk is very small.
Mentor and supervise junior Privacy Biostatisticians and partner with legal and security teams.
Truveta is a health provider led data platform that enables researchers to find cures faster and empower clinicians with data. The company is well-funded and fosters a culture of diversity, inclusion, and continuous learning.