KalVista Pharmaceuticals, Inc.
Sr.Mgr/AD, Statistical Programming
KalVista Pharmaceuticals, Inc., Cambridge, Massachusetts, us, 02140
About KalVista Pharmaceuticals, Inc.
KalVista Pharmaceuticals, Inc. is a global pharmaceutical company focused on the development and delivery of oral medicines for diseases with significant unmet need, with an initial focus on hereditary angioedema (HAE). The company disclosed positive phase 3 data for the KONFIDENT trial for its oral, on-demand therapy sebetralstat in February 2024 and submitted an NDA with the FDA in June 2024. KalVista expects to file for approval in the U.K., Europe and Japan later in 2024.
KalVista has an R&D team with an established track record in the pharmaceutical development of small molecule protease inhibitors, world-leading expertise in the role of plasma kallikrein in disease, and a management team with the capability to bring small molecules through the clinic to commercialization. Listed on the Nasdaq Global Market, our headquarters is located in Cambridge, MA with additional offices and laboratories in Salisbury, U.K.; Zug, Switzerland; Tokyo, Japan and Salt Lake City, UT.
About the role:
The Senior Manager/Associate Director, Statistical Programming will be an integral part of the clinical development team, reporting to the head of statistical programming. The statistical programmer role is to provide statistical programming and clinical data standard expertise to the team. The individual should be team oriented, collaborative, and possess a strong understanding of statistical programming and related resource management skills. Our ideal candidate will possess extensive SAS programming skills, current knowledge of CDISC standards supporting an electronic submission in the eCTD format, and strong project management skills.
Responsibilities:Development, validation, and execution of SAS programs creating SDTM datasets, analysis datasets, tables, listings, figures, and submission deliverables for clinical programsProvide subject matter expertise on electronic regulatory submissions by building submission-ready documents such as define, SDRG, ADRG and validating compiled submission packagesInteract with cross-functional clinical development team including Statistics, Clinical, Regulatory, Data Management, Clinical Operations, and Statistical Programming to plan for the statistical analysis and reporting of clinical projectsOversight and management of vendors to ensure quality and timeliness of outsourced deliverables.Provide technical guidance to colleaguesDevelop macros for programming efficienciesRequirements:
Bachelor’s degree with eight to ten years SAS programming in a clinical trial environment or Master’s degree with five plus years SAS programming in a clinical trial environmentSeven plus years in the development and execution of statistical analysis and reporting deliverablesExpertise in SAS and clinical trial programming, systems and databases including advanced knowledge of CDISC data standardsUS and/or worldwide drug regulatory application submission experience including the development of submission deliverables preferredExperience supporting advance analytics projects a plus; experience with other statistical software a plusExcellent communication skills with a demonstrated history of teamwork and collaborationAbility to handle change and challenges in a positive and professional mannerAbility to engage key stakeholders
KalVista Pharmaceuticals, Inc. is a global pharmaceutical company focused on the development and delivery of oral medicines for diseases with significant unmet need, with an initial focus on hereditary angioedema (HAE). The company disclosed positive phase 3 data for the KONFIDENT trial for its oral, on-demand therapy sebetralstat in February 2024 and submitted an NDA with the FDA in June 2024. KalVista expects to file for approval in the U.K., Europe and Japan later in 2024.
KalVista has an R&D team with an established track record in the pharmaceutical development of small molecule protease inhibitors, world-leading expertise in the role of plasma kallikrein in disease, and a management team with the capability to bring small molecules through the clinic to commercialization. Listed on the Nasdaq Global Market, our headquarters is located in Cambridge, MA with additional offices and laboratories in Salisbury, U.K.; Zug, Switzerland; Tokyo, Japan and Salt Lake City, UT.
About the role:
The Senior Manager/Associate Director, Statistical Programming will be an integral part of the clinical development team, reporting to the head of statistical programming. The statistical programmer role is to provide statistical programming and clinical data standard expertise to the team. The individual should be team oriented, collaborative, and possess a strong understanding of statistical programming and related resource management skills. Our ideal candidate will possess extensive SAS programming skills, current knowledge of CDISC standards supporting an electronic submission in the eCTD format, and strong project management skills.
Responsibilities:Development, validation, and execution of SAS programs creating SDTM datasets, analysis datasets, tables, listings, figures, and submission deliverables for clinical programsProvide subject matter expertise on electronic regulatory submissions by building submission-ready documents such as define, SDRG, ADRG and validating compiled submission packagesInteract with cross-functional clinical development team including Statistics, Clinical, Regulatory, Data Management, Clinical Operations, and Statistical Programming to plan for the statistical analysis and reporting of clinical projectsOversight and management of vendors to ensure quality and timeliness of outsourced deliverables.Provide technical guidance to colleaguesDevelop macros for programming efficienciesRequirements:
Bachelor’s degree with eight to ten years SAS programming in a clinical trial environment or Master’s degree with five plus years SAS programming in a clinical trial environmentSeven plus years in the development and execution of statistical analysis and reporting deliverablesExpertise in SAS and clinical trial programming, systems and databases including advanced knowledge of CDISC data standardsUS and/or worldwide drug regulatory application submission experience including the development of submission deliverables preferredExperience supporting advance analytics projects a plus; experience with other statistical software a plusExcellent communication skills with a demonstrated history of teamwork and collaborationAbility to handle change and challenges in a positive and professional mannerAbility to engage key stakeholders