Lead the biometrics team including statisticians, data managers, and statistical programmers at a program level, providing strategic input for clinical development.
Author and develop Statistical Analysis Plans (SAPs), contribute to trial designs, protocol development, and sample size calculations, and oversee vendor deliverables.
Interact with global health authorities, contribute to regulatory submissions, and coordinate statistical analyses for safety updates and ad hoc requests.
Spyre Therapeutics is a clinical-stage biotechnology company developing next-generation long-acting antibodies to redefine the standard of care for inflammatory bowel disease and rheumatic diseases. As a growing company, they offer a fast-paced, dynamic environment where you help shape the culture and contribute broadly to meaningful medicines.
Lead product-level biostatistics tasks including regulatory interactions and filings, ensuring statistical integrity.
Contribute to study design, sample size determination, and author/review statistical analysis plans and TFL specifications.
Mentor junior team members and collaborate cross-functionally to meet product deliverables and timelines.
Ultragenyx is a biopharmaceutical company focused on developing life-changing treatments for rare diseases. The company fosters a supportive, inclusive culture emphasizing learning and growth, enabling employees to thrive professionally and personally.
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.
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.
Lead the design, analysis, and interpretation of clinical studies for rare disease and oncology trials.
Oversee all contracted statistical activities, including protocol development, statistical analysis plans, and data review.
Provide mentorship to junior statisticians and represent the biostatistics function in cross-functional meetings and audits.
Ergomed is a specialist clinical research organization focused on rare disease and select oncology indications. With a global team across five continents, they value teamwork, flexibility, and work-life balance.
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.
Provide statistical leadership across clinical research projects, ensuring high-quality methodologies and analyses.
Collaborate with cross-functional teams to support innovative study designs and advanced statistical modeling.
Author and review Statistical Analysis Plans (SAPs), tables, listings, and figures for regulatory submissions.
The partner company provides advanced statistical expertise and scientific leadership within a collaborative biometrics and data science environment, supporting complex clinical research projects across multiple therapeutic areas. The company fosters a collaborative and supportive culture focused on technical excellence and innovation, with a team of experienced professionals.
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.
Act as a domain authority establishing benchmarks for AI-driven statistical results.
Provide knowledge sharing about day-to-day workflows and regulatory submissions.
Identify and correct discrepancies in data quality and generate reference artifacts.
Edison Scientific builds and commercializes AI agents for science. We are assembling a team of top researchers and engineers across AI and biology to build an AI scientist.
Support clinical data intake, cleaning, and preparation of analysis-ready datasets for model development and clinical validation.
Conduct exploratory and statistical analyses for retrospective and prospective oncology studies.
Generate tables, figures, and summary outputs for internal review, publications, and regulatory submissions.
Artera is an AI startup developing medical artificial intelligence tests to personalize therapy for cancer patients. It offers a 3-month graduate program with structured mentorship for statisticians to gain hands-on experience in biostatistics and AI healthcare.
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.
Provide scientific and strategic DMPK guidance across a biologics portfolio, supporting monoclonal antibodies, bispecifics, and targeted-delivery platforms.
Design and lead PK, bioanalysis, and immunogenicity studies to optimize candidate selection and progression.
Collaborate with cross-functional teams and external partners to ensure regulatory readiness and support IND filings.
Pioneering Medicines is the in-house drug development unit of Flagship Pioneering, focused on creating novel treatments from Flagship's scientific platforms. It is part of a larger organization known for innovation, with a collaborative and fast-paced culture.
Provide clinical development leadership at the study level for clinical stage assets in early and/or late development.
Serve as medical monitor for one or more studies and perform ongoing clinical trial data review.
Contribute to clinical development strategy and author clinical and regulatory documents.
Deciphera is a biopharmaceutical company focused on developing new medicines to improve the lives of people with cancer. The company fosters a collaborative culture with opportunities for personal and professional growth.
Oversee strategic and operational execution of clinical trials, leading cross-functional teams and managing vendor selection.
Direct clinical trial budgets, risk mitigation, and provide technical input into key clinical documents.
Mentor staff and foster strong team relationships in a dynamic organization.
Jade Biosciences is a clinical-stage biotechnology company developing best-in-class therapies for autoimmune diseases. The company was launched based on assets licensed from Paragon Therapeutics and has a growing pipeline.
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.
Serves as clinical trial lead, overseeing study planning, conduct, and oversight per protocol and regulations.
Develops study documents, manages site feasibility, and drives recruitment strategies.
Leads internal clinical team meetings and ensures quality deliverables through metric reporting.
Precision Medicine Group is a life sciences company that supports clinical research and development. The company is large enough to offer a range of benefits and emphasizes a collaborative, ethical culture focused on quality and compliance.
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.