Senior/Statistical Scientist - Global Medical Affairs at United Therapeutics Corporation

, North Carolina, United States -

Full Time

Start Date

Immediate

Expiry Date

06 Feb, 26

Salary

0.0

Posted On

08 Nov, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Trial Design, Biostatistics, Data Integrity, Statistical Analysis, SAS, Graphing Software, Communication, Collaboration, Statistical Methodologies, Sample Size Estimation, Data Analysis, Real World Evidence, Problem Solving, Cardiopulmonary Therapeutics, Regulatory Compliance, Statistical Concepts

Industry

Pharmaceutical Manufacturing

Description

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 and maintain a deep understanding of cardiopulmonary, respiratory and transplant therapeutics areas, staying abreast of latest research and trends to inform statistical strategies Minimum Requirements Senior Statistical Scientist, Global Medical Affairs Master’s Degree in statistics or related field with 6+ years of relevant experience or, Doctor of Philosophy (PhD) in statistics or related field with 2+ years of pharmaceutical experience in clinical development Ability to apply a wide range of statistical skills and adapt them to suit what is needed Ability to work flexibly and multi-task as needed across a broad spectrum of statistical study-related activities Proficient with SAS (base programming, macro language, SAS/GRAPH) Proficient with graphing software (SAS, Excel, R, etc.) Ability to identify data quality or analytical issues and proposing solutions for resolution Proficient working in a PC/Windows environment Ability to manage workload and prioritize appropriately to ensure timely communication of deliverables Excellent verbal and written communication skills Minimum Requirements Statistical Scientist, Global Medical Affairs Master’s Degree in statistics or related field 3+ years of relevant experience with Master's Degree or PhD (preferred) Ability to apply a wide range of statistical skills and adapt them to suit what is needed Ability to work flexibly and multi-task as needed across a broad spectrum of statistical study-related activities Proficient with SAS (base programming, macro language, SAS/GRAPH) Proficient with graphing software (SAS, Excel, R, etc.) Good understanding of clinical development and regulatory processes Proficient working in a PC/Windows environment Ability to manage workload and prioritize appropriately to ensure timely communication of deliverables Excellent verbal and written communication skills Preferred Qualifications Knowledge of cardiopulmonary, respiratory and transplant therapeutic areas Job Location This position will be located in the RTP, NC office of United Therapeutics. Currently this job is a hybrid role requiring at least three days per week in the office. In office requirements could increase based on business needs. At United Therapeutics, our mission and vision are one. We use our enthusiasm, creativity, and persistence to innovate for the unmet medical needs of our patients and to benefit our other stakeholders. We are bold and unconventional. We have fun, we do good. Eligible employees may participate in the Company’s comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit https://www.unither.com/careers/benefits-and-amenities United Therapeutics Corporation is an Equal Opportunity Employer, including veterans and individuals with disabilities. We strive to be an organization that engages the minds, hearts, and most spirited efforts of each of our employees. Our sense of purpose transforms what we do from work into mission, occupation into vocation and achievement into success. We challenge our employees with innovative and revolutionary projects, offer an environment which fosters high-level job performance and provide a highly competitive total rewards package. This is what makes United Therapeutics a stimulating place to work.

Responsibilities

The Senior/Statistical Scientist will lead biostatistical and programming activities for Phase 3b/4 clinical trials and registries, ensuring data integrity and quality. They will develop statistical analysis plans and communicate results for publication while collaborating with various teams.