Source Job

UK

  • 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.

Biostatistics Oncology Clinical Trial Design Regulatory Strategy

12 jobs similar to Associate Director, Biostatistics Consultant – Oncology

Jobs ranked by similarity.

US

  • 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.

UK

  • 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.

$173,217–$209,899/yr
US Unlimited PTO

  • 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.

Global

  • 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.

US

  • 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.

Europe

  • 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.

US Europe 5w PTO 16w maternity 6w paternity

  • 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.

UK

  • 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 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.

US

  • 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.

US

  • 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.

$144,000–$180,000/yr
US 3w PTO

  • 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.