Source Job

• Oversee CRO programming activities, including SDTM, ADaM, TFLs, define.xml, reviewer’s guides, and other clinical study or submission deliverables.
• Review CRO programming plans, specifications, datasets, outputs, QC documentation, issue logs, and submission packages.
• Collaborate with Data Management to support data cleaning, external data review, reconciliation, database lock, and data quality activities.

Braveheart Bio is a Bay Area–based biopharmaceutical company pioneering best-in-class therapies for cardiovascular disease. They have a proven leadership team, a strong financial foundation, and a high-value late-stage asset, making it an outstanding opportunity for mission-driven professionals.

• 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.

• 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.

• Prepare and submit regulatory documents to IRBs/ECs and support study start-up activities.
• Perform data entry, document cleanup, and QC during migration to Florence eRegulatory.
• Maintain CVs, licenses, and GCP documentation, partnering with coordinators, investigators, and sponsors.

UniTriTeam is a global organization that supports clinical research sites and organizations through staff augmentation and technology solutions. They pride themselves on creating opportunities for their team members while delivering exceptional results for their clients.

• 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.

• 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.

• 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.

• Lead a large clinical study or a series of related studies with minimum guidance.
• Provide mentoring and training to lower-level Data Management staff assigned to your studies.
• Develop or lead the development of the Data Management Plan for a clinical study.

Parexel provides Clinical and Consulting solutions to the world’s life sciences industry. They have a global breadth of clinical, regulatory and therapeutic expertise, and a proven track record spanning 40+ years.

• 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.

• 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.

• 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.