Accountable for all core SP deliverables (SDTM, ADAM, TFLs).
With IT, defines our programming environment and its validation.
Responsible for the development of standards, SOPs, and best practices.
Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities. Mineralys is a fully remote company that appears to be mid-sized, offering a collaborative and fast-paced environment.
Lead statistical programming activities across clinical programs, ensuring the development and quality control of tables, listings, figures, analysis datasets.
Oversee external functional service providers to ensure timely and high-quality programming deliverables.
Drive the adoption of innovative programming technologies and workflows to enhance the efficiency of clinical data review, cleaning, reconciliation, and integration.
Recursion is a clinical-stage TechBio company decoding biology to radically improve lives. The company is advancing a portfolio of differentiated investigational medicines across its wholly owned and partnered pipeline. Recursion's platform infrastructure is anchored in Salt Lake City, Utah and Milton Park, Oxfordshire.
Provide statistical support for Phase I–IV clinical trials.
Participate in protocol development, study design, and sample size calculations.
Prepare and review Statistical Analysis Plans (SAPs), TLF shells, and randomization specifications.
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. They have over 4,000 professionals in more than 20 countries with a mission to contribute to a healthier and safer world.
Develop, validate, and maintain SDTM and ADaM datasets in R following CDISC standards.
Generate Tables, Listings, and Figures (TLFs) in R or SAS as required by study needs.
Contribute to open-source and internal tooling used by clinical programming, data management, and biostatistics teams.
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. They have over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.
Develop, validate, and maintain SDTM and ADaM datasets using R following CDISC standards for clinical trial data.
Collaborate with statisticians and data teams to understand requirements and ensure deliverables meet regulatory expectations such as FDA and EMA.
Write efficient, reproducible R scripts, support TLF generation, and contribute to programming workflows, documentation, and automation initiatives.
ClinChoice is a global contract research organization (CRO) that specializes in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. With over 4,000 professionals across more than 20 countries, it fosters a diverse and inclusive culture focused on employee development and low turnover through close management and continuous training.
Contribute to the design of early/late-stage protocols across multiple therapeutic areas.
Develop and write statistical analysis plans, and perform statistical analyses for interim and final reports.
Support submission activities, including design, analysis and reporting of integrated summaries for safety and efficacy.
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, they focus on quality, professional development, and a supportive culture.
Serve as technical SME for CDISC SEND and SENDIG-AR (2019).
BryceTech is a trusted leader in complex technology domains, delivering data-driven solutions in aerospace, biosecurity, and defense. With a proven track record, they present a compelling opportunity for strategic partnerships in the GovCon space.
Represent the Biostatistics function for complex studies or at project level.
Independently contribute to design of early/late-stage protocols across multiple therapeutic areas and help draft protocols or amendments.
Develop and write statistical analysis plans and perform statistical analyses for interim and final reports to be submitted to regulatory agencies.
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. They have over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.
Primary DM contact for assigned clinical project(s) / program(s), ensuring that tasks are performed in a timely manner.
Oversee project data entry process including development of data entry guidelines, training, data entry quality and resourcing.
Develop CRF specifications from the clinical study protocol and coordinate the review/feedback from all stakeholders.
Precision for Medicine integrates clinical trial execution with scientific knowledge, laboratory expertise, and advanced data sciences to improve the speed, cost and success rate of bringing therapies to patients. They are expanding in Asia Pacific.
Lead end-to-end Clinical Data Management activities for assigned clinical studies.
Ensure clinical data are accurate, complete, consistent, and inspection-ready.
Drive proactive risk identification, issue escalation, and resolution across study teams and vendors.
Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients suffering from autoimmune diseases. They are committed to transforming the future of treatment for autoimmune disease, guided by core values and focused on innovation.
Provide strategic leadership for biometrics across all clinical development programs.
Define and implement an integrated biometrics strategy supporting clinical trial design and data quality.
Lead and oversee CROs and external vendors responsible for biostatistics statistical programming and related biometrics activities.
Braveheart Bio is a Bay Area–based biopharmaceutical company pioneering best-in-class therapies for cardiovascular disease. With a proven leadership team and a strong financial foundation, they represent an outstanding opportunity for ambitious, mission-driven professionals.
Set up, maintain, reconcile, and archive electronic and paper Trial Master Files
Track study status, enrollment, regulatory documentation, laboratory samples, and site start-up status for assigned clinical projects
Actively order and maintain ancillary clinical study supplies required for the conduct of clinical studies
Vedanta Biosciences is a late-stage biopharmaceutical company developing medicines for the treatment of gastrointestinal diseases. The company’s pipeline has been built using the company’s industry-leading product engine for the development of therapies based on defined consortia of bacteria grown from pure clonal cell banks.