Pliantrx
Senior Manager, Statistical Programming South San Francisco, CA
Pliantrx, Jackson, Mississippi, United States,
Pliant Therapeutics is a late-stage biopharmaceutical company focused on the discovery and development of novel therapies for fibrotic diseases. Founded by Third Rock Ventures with world-renowned academic thought leaders, Pliant is raising the bar to meet the unmet medical needs of physicians, patients and families impacted by fibrotic diseases. As the leader in the discovery and development of novel therapeutics for the treatment of fibrotic diseases, Pliant is developing small molecule drug candidates specifically designed to impact the fibrotic process.The Company’s lead product candidate, bexotegrast (PLN-74809), is an oral small molecule, selective inhibitor of the αvβ1 and αvβ6 integrins that play a key role in multiple fibrotic pathways. Bexotegrast has received Fast Track Designation and Orphan Drug Designation from the U.S. Food and Drug Administration for both idiopathic pulmonary fibrosis (IPF) and primary sclerosing cholangitis (PSC) and Orphan Drug Designation from the European Medicines Agency in IPF and PSC. Pliant is currently conducting BEACON-IPF, a Phase 2b/3 trial of bexotegrast for the treatment of IPF.Pliant is conducting a Phase 1 study for its third clinical program, PLN-101095, a small molecule, dual-selective inhibitor of αvß8 and αvß1 integrins, that is being developed for the treatment of solid tumors. The Company also has discovery and development programs in oncology and muscular dystrophies.Description
The Senior manager statistical programming participates in the programming activities for one or more clinical development programs by providing strategic and hands-on input in a cross-functional setting using both internal and external resources. The senior manager will oversee and participate in programming activities in support of the timely and accurate execution of statistical analysis plans supporting clinical study reports, publications, ad hoc analyses and regulatory submissions. The Senior manager will work with the department leadership to build systems and processes to support transparent, reproducible, and accurate delivery of clinical study results.This is a hybrid position, requiring 3 days/week at Pliant (South San Francisco). The position reports to the Head of Programming and will work closely with a cross-functional team in a fast-paced high growth environment team to ensure that clinical data are complete, high quality and delivered on time and budget.Responsibilities
Responsible for leading the programming activities on multiple projects/studies.Responsible for reviewing and providing technical input into documents produced by other functions (e.g. biostatisticians, data managers, medical writers).Responsible for providing programming expertise to review/QC the programming work provided by external CRO, including timeline along with QC outputs, datasets, and programming related documents, and debugging programming errors.Accountable for all statistical programming, including programming SDTM, ADaM datasets, tables, figures and listings (TFLs), authoring dataset specifications, providing quality control for datasets, TFLs, maintaining records and timelines, identifying and communicating changes in project requirements that may affect key deliverables.Accountable for the execution of statistical analysis plans that support clinical development plans and clinical protocols, to ensure transparency, adequacy and accuracy.Responsible for contributing to the development of departmental macros, work instructions, and departmental initiatives, such as creating ADaM dataset standards and TLF mock shells.Collaborate with Biostatistics, Data Management, Clinical Operations, Clinical Development, Regulatory and Project Management management/staff to meet project deliverables and timelines for statistical data analysis and reporting.Qualifications
To perform this job successfully, an individual must be able to perform each essential duty. The requirements listed below are representative of the knowledge, skill, abilities and prior experience required.Bachelor or Masters degree in a scientific or computer sciences discipline.Minimum of 8+ years of clinical trial programming experience in the biotechnology, pharmaceutical or health related industry; 6 years with a Masters degree.Advanced SAS programming skills.Experience in other statistical software, such as R is a plus.Experience and in-depth knowledge in CDISC including SDTM, ADaM and controlled terminologies and Pinnacle 21 validator.Comprehensive knowledge of FDA/EMA/ICH guidelines for statistical and clinical data analysis, data structure, and new developments and industry standards in statistical programming.Experience in building programming packages for NDA/MAA submissions is preferred.Experience managing external programming resources is preferred.Knowledge of clinical data management systems.Able to collaborate effectively with internal, cross-functional and external study teams to meet project timelines.Self-directed, technically strong, and a leader maintaining a strategic prospective with regard to statistical programming processes and the management of statistical programming projects.Excellent organizational skills and attention to detail.Able to set priorities and juggle multiple projects and demands.Able to work independently while exercising initiative, flexibility and sound judgment.Ability to operate in alignment with Pliant’s values.
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The Senior manager statistical programming participates in the programming activities for one or more clinical development programs by providing strategic and hands-on input in a cross-functional setting using both internal and external resources. The senior manager will oversee and participate in programming activities in support of the timely and accurate execution of statistical analysis plans supporting clinical study reports, publications, ad hoc analyses and regulatory submissions. The Senior manager will work with the department leadership to build systems and processes to support transparent, reproducible, and accurate delivery of clinical study results.This is a hybrid position, requiring 3 days/week at Pliant (South San Francisco). The position reports to the Head of Programming and will work closely with a cross-functional team in a fast-paced high growth environment team to ensure that clinical data are complete, high quality and delivered on time and budget.Responsibilities
Responsible for leading the programming activities on multiple projects/studies.Responsible for reviewing and providing technical input into documents produced by other functions (e.g. biostatisticians, data managers, medical writers).Responsible for providing programming expertise to review/QC the programming work provided by external CRO, including timeline along with QC outputs, datasets, and programming related documents, and debugging programming errors.Accountable for all statistical programming, including programming SDTM, ADaM datasets, tables, figures and listings (TFLs), authoring dataset specifications, providing quality control for datasets, TFLs, maintaining records and timelines, identifying and communicating changes in project requirements that may affect key deliverables.Accountable for the execution of statistical analysis plans that support clinical development plans and clinical protocols, to ensure transparency, adequacy and accuracy.Responsible for contributing to the development of departmental macros, work instructions, and departmental initiatives, such as creating ADaM dataset standards and TLF mock shells.Collaborate with Biostatistics, Data Management, Clinical Operations, Clinical Development, Regulatory and Project Management management/staff to meet project deliverables and timelines for statistical data analysis and reporting.Qualifications
To perform this job successfully, an individual must be able to perform each essential duty. The requirements listed below are representative of the knowledge, skill, abilities and prior experience required.Bachelor or Masters degree in a scientific or computer sciences discipline.Minimum of 8+ years of clinical trial programming experience in the biotechnology, pharmaceutical or health related industry; 6 years with a Masters degree.Advanced SAS programming skills.Experience in other statistical software, such as R is a plus.Experience and in-depth knowledge in CDISC including SDTM, ADaM and controlled terminologies and Pinnacle 21 validator.Comprehensive knowledge of FDA/EMA/ICH guidelines for statistical and clinical data analysis, data structure, and new developments and industry standards in statistical programming.Experience in building programming packages for NDA/MAA submissions is preferred.Experience managing external programming resources is preferred.Knowledge of clinical data management systems.Able to collaborate effectively with internal, cross-functional and external study teams to meet project timelines.Self-directed, technically strong, and a leader maintaining a strategic prospective with regard to statistical programming processes and the management of statistical programming projects.Excellent organizational skills and attention to detail.Able to set priorities and juggle multiple projects and demands.Able to work independently while exercising initiative, flexibility and sound judgment.Ability to operate in alignment with Pliant’s values.
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