Senior/Statistical Scientist - Global Medical Affairs

California, US residents click here.

The job details are as follows:

Who We Are

We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purpose is to provide a brighter future for patients through the development of novel pharmaceutical therapies; and technologies that expand the availability of transplantable organs.

United Therapeutics (Nasdaq: UTHR) seeks to travel down the corridors of indifference to develop treatments for rare, deadly diseases. We were founded in 1996 by a family seeking a cure for their daughter’s pulmonary arterial hypertension (PAH). Today, we have six FDA-approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung disease (PH-ILD) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis (PF).

The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an organ transplant, but only a small percentage of donated organs are available to address the vast need. For this reason, we are working to create manufactured organs to address the shortage of kidneys, hearts, lungs, and livers available for transplant. We believe an unlimited supply of tolerable, transplantable organs will eliminate the transplant waiting list and cure end-stage organ diseases for which transplant is not currently an option.

Who You Are

You are a detail-oriented person who has a strong understanding of clinical trial and registry design. You are able to effectively communicate complex biostatistics and collaborate strategically with colleagues and external partners. You are thoughtful and excited to part of a company that is forward thinking and innovative.

The Senior/Statistical Scientist, Global Medical Affairs will contribute to all biostatistical and programming activities related to various company-sponsored Phase 3b/4 clinical trials and registries and other real-world evidence generation. Individual will lead development of the statistical analysis plan, ensure data integrity and quality of collected data and execution/programming of the statistical analysis plan. Communicate and collaborate in a highly matrixed organization to disseminate study results for publication into abstracts, posters and manuscripts.

• Act as the lead project statistician for assigned phase 3b/4 clinical trials, leading the development and implementation of statistical methodologies and ensuring the integrity and accuracy of data analysis
• Conduct comprehensive statistical design, including sample size estimation and randomization specifications.
• Develop statistical analysis plans and perform data analysis to drive evidence-based decision making
• Collaborate with data management, clinical development and medical strategy personnel to align on phase 3b/4 clinical trial objectives, streamline processes, and ensure the successful achievement of trial goals
• Ensure data integrity and quality as received from the electronic data capture or external vendor data working with the data manager to identify and resolve issues as identified
• Execution of the statistical analysis plan at interim analyses and database lock, ensuring high-quality outputs (tables and figures)
• Coordinate with the Medical Affairs team and other stakeholders to provide biostatistical resources for investigator-sponsored clinical studies and address internal/external investigator queries of UT clinical databases
• Provide expert input, conduct thorough reviews, and grant approval for submitted investigator-sponsored clinical studies, external investigator queries of UT databases, abstracts, manuscripts, and posters, ensuring scientific validity and compliance with regulatory standards
• Collaborate with HEOR to support and execute real world evidence studies using data including, but not limited to administrative claims, specialty pharmacy shipments and electronic health records as requested
• Communicate highly technical statistical concepts to non-statisticians, translate clinical questions into statistical analyses, and facilitate understanding across multidisciplinary teams
• Discuss and resolve issues or concerns related to statistical analyses with external investigators and internal colleagues, fostering a collaborative problem-solving environment
• Develop an