NCBiotech
Senior/Statistical Scientist - Global Medical Affairs
NCBiotech, California, Missouri, United States, 65018
California, US residents (information available upon request).
Overview
The job details are as follows. We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation with a public benefit purpose to provide a brighter future for patients through novel pharmaceutical therapies and technologies that expand 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 PAH. Today, we have six FDA-approved therapies for PAH, PH-ILD and neuroblastoma, and our near-term pipeline aims to expand therapies for PAH and PF. We are pursuing manufactured organs to address organ shortages and the transplant waiting list. We are focused on advancing therapies and technologies to improve patient outcomes and expand access to transplantable organs. Who You Are You are a detail-oriented professional with a strong understanding of clinical trial and registry design. You communicate complex biostatistics clearly, collaborate effectively with colleagues and external partners, and are excited to contribute to a forward-thinking, innovative company. Responsibilities
Act as the lead project statistician for assigned phase 3b/4 clinical trials, leading the development and implementation of statistical methodologies and ensuring data integrity and accuracy of analyses Conduct comprehensive statistical design, including sample size estimation and randomization specifications Develop statistical analysis plans and perform data analyses to support evidence-based decision making Collaborate with data management, clinical development, and medical strategy to align trial objectives, streamline processes, and achieve trial goals Ensure data integrity and quality from electronic data capture or external vendors, working with the data manager to identify and resolve issues Execute the statistical analysis plan at interim analyses and database locks, producing high-quality outputs (tables and figures) Coordinate with Medical Affairs and other stakeholders to provide biostatistical resources for investigator-sponsored studies and address queries Provide expert input, review, and approval for submitted investigator-sponsored studies, external queries, abstracts, manuscripts, and posters, ensuring scientific validity and regulatory compliance Collaborate with HEOR to support real-world evidence studies using data such as administrative claims, specialty pharmacy data, and EHRs Translate highly technical statistical concepts for non-statisticians and facilitate understanding across multidisciplinary teams Resolve statistical analysis issues with external investigators and internal colleagues through collaborative problem-solving Develop and maintain understanding of cardiopulmonary, respiratory, and transplant therapeutics 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 needs Ability to work flexibly and multi-task across 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 propose solutions Proficient in a PC/Windows environment Ability to manage workload and prioritize to ensure timely 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 needs Ability to work flexibly and multi-task across 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 to ensure timely deliverables Excellent verbal and written communication skills Preferred Qualifications
Knowledge of cardiopulmonary, respiratory and transplant therapeutic areas Job Location
The position will be located in the RTP, NC office of United Therapeutics. It is a hybrid role requiring at least three days per week in the office, with in-office requirements potentially increasing based on business needs. At United Therapeutics, our mission and vision are one. We drive innovation for unmet medical needs and benefit our stakeholders with enthusiasm, creativity, and persistence. We are bold, unconventional, and we strive to have fun while doing good. Eligible employees may participate in the Company’s comprehensive benefits suite, including medical/dental/vision/prescription coverage, wellness resources, savings plans (401k and ESPP), paid time off and parental leave, disability benefits, and more. For additional information on Company benefits, please visit the following URL: https://www.unither.com/careers/benefits-and-amenities United Therapeutics Corporation is an Equal Opportunity Employer, including veterans and individuals with disabilities.
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The job details are as follows. We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation with a public benefit purpose to provide a brighter future for patients through novel pharmaceutical therapies and technologies that expand 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 PAH. Today, we have six FDA-approved therapies for PAH, PH-ILD and neuroblastoma, and our near-term pipeline aims to expand therapies for PAH and PF. We are pursuing manufactured organs to address organ shortages and the transplant waiting list. We are focused on advancing therapies and technologies to improve patient outcomes and expand access to transplantable organs. Who You Are You are a detail-oriented professional with a strong understanding of clinical trial and registry design. You communicate complex biostatistics clearly, collaborate effectively with colleagues and external partners, and are excited to contribute to a forward-thinking, innovative company. Responsibilities
Act as the lead project statistician for assigned phase 3b/4 clinical trials, leading the development and implementation of statistical methodologies and ensuring data integrity and accuracy of analyses Conduct comprehensive statistical design, including sample size estimation and randomization specifications Develop statistical analysis plans and perform data analyses to support evidence-based decision making Collaborate with data management, clinical development, and medical strategy to align trial objectives, streamline processes, and achieve trial goals Ensure data integrity and quality from electronic data capture or external vendors, working with the data manager to identify and resolve issues Execute the statistical analysis plan at interim analyses and database locks, producing high-quality outputs (tables and figures) Coordinate with Medical Affairs and other stakeholders to provide biostatistical resources for investigator-sponsored studies and address queries Provide expert input, review, and approval for submitted investigator-sponsored studies, external queries, abstracts, manuscripts, and posters, ensuring scientific validity and regulatory compliance Collaborate with HEOR to support real-world evidence studies using data such as administrative claims, specialty pharmacy data, and EHRs Translate highly technical statistical concepts for non-statisticians and facilitate understanding across multidisciplinary teams Resolve statistical analysis issues with external investigators and internal colleagues through collaborative problem-solving Develop and maintain understanding of cardiopulmonary, respiratory, and transplant therapeutics 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 needs Ability to work flexibly and multi-task across 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 propose solutions Proficient in a PC/Windows environment Ability to manage workload and prioritize to ensure timely 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 needs Ability to work flexibly and multi-task across 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 to ensure timely deliverables Excellent verbal and written communication skills Preferred Qualifications
Knowledge of cardiopulmonary, respiratory and transplant therapeutic areas Job Location
The position will be located in the RTP, NC office of United Therapeutics. It is a hybrid role requiring at least three days per week in the office, with in-office requirements potentially increasing based on business needs. At United Therapeutics, our mission and vision are one. We drive innovation for unmet medical needs and benefit our stakeholders with enthusiasm, creativity, and persistence. We are bold, unconventional, and we strive to have fun while doing good. Eligible employees may participate in the Company’s comprehensive benefits suite, including medical/dental/vision/prescription coverage, wellness resources, savings plans (401k and ESPP), paid time off and parental leave, disability benefits, and more. For additional information on Company benefits, please visit the following URL: https://www.unither.com/careers/benefits-and-amenities United Therapeutics Corporation is an Equal Opportunity Employer, including veterans and individuals with disabilities.
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