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.
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.
Leads statistical activities for clinical studies in oncology.
Authors statistical sections of study protocols, analysis plans, and regulatory documents.
Collaborates with cross-functional teams and CROs to ensure high-quality deliverables.
Iovance Biotherapeutics develops tumor infiltrating lymphocyte (TIL) therapy for cancer treatment. The company is a global leader in cell therapy innovation with a focus on clinical data and regulatory submissions.
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.
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.
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.
Develop, validate, and maintain SAS and/or R programs for SDTM, ADaM datasets, and TLFs per CDISC standards.
Support statistical analyses for regulatory submissions, safety reports, and clinical study reports in a GxP-compliant environment.
Collaborate with cross-functional teams to define analysis specifications and perform quality control on statistical outputs.
Iovance Biotherapeutics is a global leader in innovating, developing, and delivering tumor infiltrating lymphocyte (TIL) therapy for cancer. The company is a fast-paced biotech with a collaborative culture, committed to continuous innovation in cell therapy.
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.
Design, develop, and validate CDISC-compliant SDTM and ADaM datasets for clinical trials.
Support regulatory submissions including ISS, ISE, and create Tables, Listings, and Figures.
Collaborate with cross-functional teams to deliver accurate statistical outputs for evidence-based healthcare.
The partner company is a clinical research organization that supports impactful clinical programs through statistical programming. It offers a collaborative culture and a flexible remote work environment.
Develop, validate, and maintain SDTM and ADaM datasets using R following CDISC standards.
Support TLF generation in R or SAS as needed for clinical trial deliverables.
Collaborate with biostatistics and clinical data teams to ensure regulatory compliance and quality.
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, and medical device companies. They have over 4,000 professionals in more than 20 countries and emphasize a culture of low turnover, diversity, and inclusivity.
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.
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.
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.
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.
Provide senior statistical leadership across clinical development projects in ophthalmology.
Lead statistical analysis plans, study design, and regulatory submissions.
Mentor biostatistics professionals and collaborate with cross-functional teams.
The partner company specializes in clinical research and statistical leadership for ophthalmology programs. It offers a fully remote European work environment with a collaborative culture and opportunities for career development.
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.
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.
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.