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.
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.
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 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.
Plan and execute development experiments for Freenome's multiomics cancer screening tests.
Partner cross-functionally with computational, development, regulatory, and quality teams to develop a regulated strategy toward FDA approval.
Use quantitative skills to develop computational methods and interpret complex experimental results to optimize and validate innovative technology.
Freenome is a biotechnology company developing early, noninvasive blood-based tests for cancer detection. The company emphasizes a highly collaborative, cross-functional environment and values diversity.
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 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.
Transform real-world, clinical, and preclinical data into reproducible datasets and analyses.
Provide biostatistical support for study design, analysis planning, and statistical programming across the product lifecycle.
Collaborate with cross-functional teams and communicate analytical insights to technical and nontechnical stakeholders.
Calyxo, Inc. is a medical device company focused on transforming kidney stone treatment with innovative devices. Founded in 2016, the company offers a dynamic, diverse, and collaborative culture led by experienced executives and investors.
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.