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.
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.
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 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 statistician for clinical studies, responsible for study design, analysis, and documentation.
Collaborate with cross-functional teams and manage external vendor work.
Provide statistical expertise for regulatory submissions and act as subject matter expert.
Jazz Pharmaceuticals is a global biopharma company developing life-changing medicines for serious diseases, focusing on oncology and neuroscience. With employees in multiple countries, it fosters a patient-focused, science-driven 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.
Own statistical strategy across the portfolio while staying hands-on as lead statistician on live programmes.
Serve as primary statistical interface with regulators and assess in-licensing assets' statistical rigour during due diligence.
Build and lead the biostatistics, statistical programming, and medical writing functions as the team grows.
Lindus Therapeutics is building the next generation of biopharma by in-licensing clinical-stage assets and developing them through Lindus Health's technology-first clinical trial infrastructure. It is a new, small team with a proven foundation of 40+ completed trials.
Lead statistical programming activities across multiple studies, ensuring quality and timely delivery.
Develop and validate TLFs, SDTM/ADaM datasets, Define-XML, and SAS programs.
Provide technical oversight, mentoring, and collaboration with cross-functional teams.
ClinChoice is a global full-service CRO providing clinical development and functional solutions for pharma, biotech, medical device, and consumer health companies. With over 4,000 professionals across 20+ countries, they value continuous training, diversity, and inclusion.
Lead statistical strategy across multiple complex clinical, diagnostic, and evidence-generation studies.
Serve as a senior statistical expert to clinical, scientific, regulatory, and product stakeholders.
Mentor statisticians, establish analytical best practices, and influence study design and regulatory responses.
Karius is a venture-backed clinical metagenomics company that uses genomics and AI to detect microbial cell-free DNA in blood, helping physicians diagnose infectious diseases. The company is committed to advancing diagnostic science and fostering a diverse, inclusive workplace.
Serve as study statistician for Phase 1-3 vaccine clinical trials, leading statistical design, analysis, and reporting.
Oversee statistical CROs, develop analysis plans, and ensure regulatory and scientific rigor.
Provide statistical consultation across CVIA programs and represent PATH at scientific meetings.
PATH is a global nonprofit dedicated to achieving health equity, developing and scaling innovative solutions to pressing health challenges. With more than 40 years of experience, PATH fosters a culture of collaboration and partnership across diverse teams.
Lead regulatory strategy for oncology drug development programs, ensuring alignment with US and global health authorities.
Plan and manage Clinical Trial Applications, Market Applications, and amendments with high-quality submissions.
Collaborate cross-functionally to integrate evolving regulations and drive process improvements.
Iovance Biotherapeutics is a global leader in developing and delivering tumor infiltrating lymphocyte (TIL) cell therapies for solid tumors, with an FDA-approved treatment for advanced melanoma. The company operates as an end-to-end cell therapy organization with U.S.-based manufacturing, serving thousands of cancer patients worldwide.
Lead and manage the assigned clinical operations team, setting and executing departmental strategy.
Oversee clinical trial agreements, budgets, and the timely execution of clinical research programs from conception through final study report.
Maintain oversight of study conduct at sites, ensure adherence to protocols and GCP, and serve as company representative at external meetings.
Iovance Biotherapeutics is the global leader in innovating, developing, and delivering tumor infiltrating lymphocyte (TIL) cell therapies for patients with solid tumors. As an end-to-end cell therapy company with fully owned, centralized U.S.-based manufacturing, it operates with a fast-paced, collaborative culture focused on bringing first-in-class treatments to cancer patients.
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.
Provide statistical programming support across oncology programs.
Oversee and review the quality of CRO programming deliverables.
Create, review, and validate SDTM, ADaM, and TFLs.
Vir Biotechnology is a clinical-stage biopharmaceutical company focused on powering the immune system to transform lives by developing medicines for serious infectious diseases and cancer. The company emphasizes a supportive, collaborative culture where colleagues' success drives its mission.
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.
Serve as primary point-of-contact liaison with clients and oversee all aspects of clinical trials.
Manage study budgets, project timelines, risk, and cross-functional teams to ensure quality and compliance.
Drive bid defense preparation, client presentations, and continuous process improvement across assigned portfolios.
Precision for Medicine supports clinical research and development for biopharmaceutical and life science companies. It is a global, collaborative organization that emphasizes quality, innovation, and professional growth.
Lead full service clinical projects in Oncology, ensuring timelines, budget, and quality.
Serve as primary client liaison and coordinate cross-functional teams across all study stages.
Manage all aspects of clinical trials, including proposal strategy, documentation, and reporting.
Precision for Medicine is a CRO enabling precision medicine through novel clinical trial designs, biomarker and data analytics, and a focus on rare diseases and oncology. We are a supportive, collaborative team that values work life balance and development.