Source Job

US

  • Lead statistical activities for clinical trials, primarily in Oncology, and act as the lead statistician overseeing strategy and deliverables.
  • Author key documents including Statistical Analysis Plans (SAPs), Analysis Database Specifications, and statistical sections of clinical study reports.
  • Collaborate with cross-functional teams, communicate results to stakeholders, and ensure regulatory compliance with FDA, ICH, and GCP standards.

Statistics Biostatistics Oncology SAS Regulatory Compliance

20 jobs similar to Senior Principal Biostatistician/Senior Manager, Biostatistician - Study Lead (Oncology)

Jobs ranked by similarity.

US

  • Provide high-level consulting services for statistical analysis, reporting, and programming in clinical trials.
  • Develop and validate statistical analysis plans, randomization schedules, and clinical trial reports.
  • Mentor statistical programmers and ensure compliance with regulatory guidelines like ICH, GCP, and 21 CFR Part 11.

eClinical Solutions helps life sciences organizations accelerate clinical development initiatives with expert data services and the elluminate Clinical Data Cloud. It is a fast-growing company that has won the 2025 Top Workplaces USA Award for Remote Work and emphasizes an inclusive culture and work-life balance.

$193,500–$250,500/yr
US Unlimited PTO

  • Provide statistical support for clinical trials, including protocol design, analysis plans, and database monitoring.
  • Serve as biostatistics lead for studies, publications, and regulatory submissions.
  • Ensure study designs are scientifically sound and meet regulatory requirements for efficacy and safety.

Replimune is a biotechnology company pioneering oncolytic immunotherapies to transform cancer treatment. Founded in 2015, the company values collaboration, boldness, dedication, and honesty.

$200,000–$230,000/yr
US

  • Lead the full scope of Biostatistics activities for assigned clinical programs, including study design, analysis, and regulatory submissions.
  • Collaborate cross-functionally with Clinical, Medical, and Regulatory teams to ensure quality and timely delivery of statistical outputs.
  • Oversee CROs and internal teams, supervise statistical programming, and drive continuous improvement in biostatistics processes.

Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities. The company is headquartered in Radnor, Pennsylvania and operates as a fully remote organization.

US

  • Provide statistical oversight and lead complex programs such as NDA/BLA/MAA submissions.
  • Consult with clients on clinical trial study design and regulatory strategy.
  • Author statistical analysis plans and review statistical output for accuracy.

Precision Medicine Group provides statistical leadership and support for clinical development, consulting with clients on trial design and regulatory strategy. The company is a global organization that values collaboration, service, and accountability, fostering a culture of mentoring and innovation.

European Union

  • Serve as study statistician or support statistician on Bronchiectasis or Hepatitis B programs, responsible for protocol development, study design, sample size calculation, randomization, and statistical analysis plans.
  • Provide statistical oversight to studies, assure data completeness and accuracy, and ensure validity of analysis and alternative strategies when unforeseen circumstances arise.
  • Demonstrate extensive understanding of statistical concepts, correct flaws in reasoning and interpretation, and ensure accuracy of statistical tables, figures, and report text.

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 28 years of experience and more than 4,000 professionals in over 20 countries across the Americas, Europe, and Asia-Pacific, the company emphasizes quality, professional development, and a supportive culture.

$130,900–$163,600/yr
US

  • Design and review statistical methodology for clinical trial protocols and analysis plans.
  • Lead execution of statistical analyses for regulatory submissions and exploratory studies.
  • Effectively convey complex statistical concepts to cross-functional teams and stakeholders.

Natera is a global leader in cell-free DNA testing for oncology, women's health, and organ health. The team consists of highly dedicated professionals from world-class institutions who care deeply about their work and each other.

$136,960–$205,440/yr
US

  • Provide expert technical support and leadership in clinical trial reporting using advanced SAS features.
  • Perform quality control checks and ensure accuracy and consistency of SAS code and output.
  • Collaborate with cross-functional teams to support electronic submissions and compliance with regulatory standards.

Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. With over 30 years of history, the company is consistently recognized as one of the industry's top places to work, including 14 consecutive years on Science magazine's Top Employers list and one of Fortune’s 100 Best Companies to Work For.

US

  • Participate in CRF design, database review, and data validation procedures to ensure data integrity.
  • Produce data listings, summary tables, and graphics for interim and final analyses of clinical trials.
  • Collaborate with Biometrics functions and coordinate data transfer standards with CROs and vendors.

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 across the Americas, Europe, and Asia-Pacific, they maintain a supportive culture focused on quality, professional development, and low turnover.

Global

  • Provide leadership and mentorship across regional clinical trials while ensuring high-quality study execution with minimal travel.
  • Oversee monitoring visit reports, manage study risks, and ensure compliance with corrective measures at country and regional levels.
  • Collaborate with cross-functional teams, lead project calls, and deliver training to support data integrity and site performance.

PSI CRO is a privately owned, global Contract Research Organization dedicated to advancing medical science and bringing new therapies to patients worldwide. Founded in 1995, the company has over 3,000 employees and prides itself on long-term stability, having never undergone a merger, acquisition, or company-wide layoffs.

$116,000–$151,000/yr
US

  • Provide statistical support for HEOR, RWE, and Market Access activities under the guidance of senior leadership.
  • Collaborate with cross-functional teams to design studies, analyze data from clinical trials, claims databases, and registries.
  • Apply statistical methodologies and SAS/R programming to transform data into actionable insights for decision making.

Travere Therapeutics is a biopharmaceutical company dedicated to identifying, developing, and delivering life-changing therapies for people living with rare diseases. The company fosters a collaborative, diverse, and fast-paced culture with a global team that is passionate about making a difference for rare patients.

$158,000–$227,000/yr
US 3w PTO

  • Manage a team of statistical programmers supporting clinical research and ensuring quality, integrity, and timely delivery of programming deliverables.
  • Provide statistical programming support, oversee development of code for Tables, Listings, and Figures, and ensure compliance with quality processes.
  • Lead resource planning, manage CROs, and contribute to process improvements and innovation in statistical programming standards.

Penumbra is a global healthcare company focused on innovative therapies, designing and marketing novel products for challenging medical conditions. It sells primarily through a direct sales organization in the US, Europe, Canada, and Australia.

$117,446–$176,168/yr
USA

  • Independently perform statistical analyses for clinical studies and research initiatives.
  • Develop statistical analysis plans, including sample size and power calculations.
  • Collaborate with cross-functional teams to ensure statistical rigor and appropriate interpretation of results.

Karius is a life science, venture-backed clinical metagenomics company focused on elevating patient care through microbial insights. The company delivers unprecedented diagnostic insight detecting microbial cell-free DNA to assist physicians in making rapid treatment decisions.

US

  • Develops and analyzes research data using statistical methods, assisting researchers with study protocols and computer analyses.
  • Manages computer systems, writes programs, and trains others in their use, providing statistical expertise in study design and data analysis.
  • Consults with investigators to determine research questions, performs appropriate statistical analyses, and documents methods and results in reports.

Emory University is a leading research university that fosters excellence and attracts world-class talent to innovate today and prepare leaders for the future. It is a large institution with a diverse academic community, committed to equal opportunity and affirmative action.

US

  • You will lead global regulatory strategy for drug development programs, focusing on Ex-US health authorities.
  • You will manage and create high-quality regulatory submissions, including Clinical Trial Applications and Market Applications.
  • You will collaborate cross-functionally to negotiate optimal development paths and ensure compliance with evolving regulations.

Iovance Biotherapeutics is a biotechnology company focused on developing tumor infiltrating lymphocyte (TIL) therapy for cancer treatment. The company is committed to innovation in cell therapy and has a clinical-stage pipeline.

Global

  • Leads a global team of Statistical Programmers, overseeing SDTM, ADaM, and TLF deliverables.
  • Ensures quality, budget, and timeline adherence while mentoring team members.
  • Contributes to process improvements and strategic initiatives to enhance operational efficiency.

Ergomed is a specialist clinical research organization focused on rare disease and oncology clinical trials. They have built a collaborative, international team across multiple continents, valuing teamwork, flexibility, and work-life balance.

US

  • Leads the planning, conduct, and oversight of clinical studies per scope of work, ensuring compliance with protocols, SOPs, and regulatory requirements.
  • Acts as primary clinical point of contact for clients, develops study documents, and drives site feasibility and recruitment strategies.
  • Manages clinical teams, training, vendor oversight, and ensures data quality and timely deliverables across study phases.

Precision Medicine Group is a clinical research organization that provides outsourced clinical trial management services to pharmaceutical and biotechnology companies. The company fosters a collaborative culture focused on quality and compliance, and employs a team of experienced clinical professionals.

Europe

  • Provide strategic statistical expertise across the full lifecycle of clinical studies, from protocol development to clinical study reporting.
  • Mentor statisticians and ensure excellence in project delivery while collaborating with multidisciplinary global teams.
  • Influence complex clinical programs and contribute to the development of new therapies through high-quality data-driven decision-making.

This company provides clinical research services and statistical expertise for early-phase drug development. It fosters an inclusive, collaborative culture with opportunities for career growth and mentorship.

US

  • Provide statistical leadership and consultation for an international real-world clinico-genomic data consortium.
  • Develop statistical analysis plans, perform statistical programming in R, and design observational studies.
  • Collaborate with investigators, pharmaceutical clients, and academic institutions to translate research questions into rigorous analyses.

The American Association for Cancer Research (AACR) is the first and largest organization in the world dedicated to advancing cancer research, with over 61,000 members in 143 countries. It fosters collaboration among scientists, physicians, and patient advocates to prevent and cure cancer through publications, conferences, and advocacy.

US

  • Lead the development and execution of statistical analysis plans for large-scale real-world evidence studies.
  • Work directly with cross-functional teams and senior stakeholders to design data-driven solutions for a high-profile sponsor.
  • Oversee and mentor junior analysts, driving best practices and innovative analytics workflows.

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 emphasizes a supportive culture, continuous training, and below-industry-average turnover rates.

US

  • Lead and develop clinical operations teams, overseeing oncology trial execution from feasibility to closeout.
  • Drive process improvements and operational excellence to enhance study delivery and site performance.
  • Ensure compliance with regulations, manage budgets and resources, and foster stakeholder relationships.

The company is a global clinical development organization focused on advancing oncology therapies through clinical trials. It fosters a collaborative and inclusive work environment with opportunities for professional growth and continuous learning.