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 and support all programming activities for clinical studies, including developing Tables, Figures, and Listings (TFLs) using SAS for Clinical Study Reports and regulatory submissions.
Work independently to implement programming strategies, ensure compliance with standards, and contribute to best practices for quality and efficiency.
Communicate and escalate risks, support team activities, and coordinate with biostatisticians to customize outputs for target audiences.
ClinChoice is a global full-service clinical research organization 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 across 20+ countries, the company fosters a supportive culture focused on quality, professional development, and low employee turnover.
Responsible for protocol development including study design, sample size calculation, randomization, and statistical analysis plan for assigned studies.
Provide statistical oversight to studies and assure adequate quality and consistency with project requirements.
Mentors peers on statistical methodology and manages activities of statisticians across projects.
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, we have a supportive culture and below industry average turnover rates.
Partner with medical and cross-functional teams to provide statistical leadership for real-world evidence and publication strategies.
Perform advanced statistical analyses including meta-analyses, causal inference, and external control studies.
Write statistical analysis plans, review medical literature, and ensure quality of statistical programming.
ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. The company offers the security and career opportunities of a global organization while allowing direct work with a single sponsor.
Lead global regulatory strategy for one or more drug development programs, with emphasis on submissions and health authority interactions.
Plan, manage, and create Clinical Trial Applications, Market Applications, and amendments, ensuring high-quality documents.
Collaborate with cross-functional teams to create and negotiate clinical-regulatory development paths and prepare for health authority meetings.
Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. They are committed to continuous innovation in cell therapy, including gene-edited cell therapy, which may be a promising option for patients with cancer.