Ascendis Pharma A/S
Senior Manager, Statistical Programming: Job ID - 1291
Ascendis Pharma A/S, Palo Alto, California, United States, 94306
The Senior Manager, Statistical Programmer will be expected to provide timely support to the study team on all programming matters according to project strategies. This role is focused on supporting the team. The incumbent should have hands-on skills and experiences in implementing and executing programming and project standards to support in production or validation of CDISC SDTM, ADaM datasets, and Tables, Listings, Figures for clinical study reports, ISS, or ISE for assigned projects. Independently provide programming support to statisticians in planned analysis, adhoc analysis, and demonstrate SAS programming proficiency. This position will be responsible for leading the programming aspect of a project for all programming deliverables from the single study through to regulatory approval. This position requires comprehensive knowledge of CDISC standards, clinical trial study design, and electronic data submission requirements. Work collaboratively with the study team to meet study deliverables and timeline for statistical data analysis and reporting.Other responsibilities include but are not limited to: develop and maintain standard programs, macros, templates, and libraries for use in clinical studies. The position will be based in Palo Alto or may be remote.Key Responsibilities
Develop an expertise within a therapeutic area or standard tool for Statistical Programming function.Participate in study team meetings to represent the Statistical Programming function to support or lead the study, focusing on data integrity, collaboration, and on-time deliverables.Have a good understanding to follow an analysis plan and prepare standard study SDTM, ADaM data specifications and provide programming support for all required deliverables.Process clinical data required for statistical analysis. Develop SAS code or macros for preparing, processing, and analyzing clinical data.Interact with members of project teams, statisticians, and data management personnel to perform statistical programming activities.Provide support in the production or validation of summary tables, data listings, and graphs required for trial reports and clinical development, and CDISC datasets for regulatory submission.Minimum Requirements
A bachelor’s degree in statistics, mathematics, or equivalent with at least 10 years of experience in the pharmaceutical or bio-pharmaceutical industry or a master’s degree with at least 7 years in statistics or computer science is preferred.Demonstrated good verbal and written communication skills and interpersonal skills.Self-motivated, with initiative and the ability to take ownership of, and follow through with, specific tasks.Ability to multi-task and shift priorities quickly while working under tight deadlines.New hires based in the US will be required to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption or accommodation to this vaccination requirement, subject to applicable law.Estimated salary: 160-175K/year.A note to recruiters:
We do not allow external search party solicitation. Presentation of candidates without written permission from the Ascendis Pharma Inc Human Resources team (specifically from: Talent Acquisition Partner or Human Resources Director) is not allowed. If this occurs your ownership of these candidates will not be acknowledged.Benefits
Medical insuranceVision insuranceDental insurance401(k)Paid maternity leavePaid paternity leaveCommuter benefitsDisability insurance
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Develop an expertise within a therapeutic area or standard tool for Statistical Programming function.Participate in study team meetings to represent the Statistical Programming function to support or lead the study, focusing on data integrity, collaboration, and on-time deliverables.Have a good understanding to follow an analysis plan and prepare standard study SDTM, ADaM data specifications and provide programming support for all required deliverables.Process clinical data required for statistical analysis. Develop SAS code or macros for preparing, processing, and analyzing clinical data.Interact with members of project teams, statisticians, and data management personnel to perform statistical programming activities.Provide support in the production or validation of summary tables, data listings, and graphs required for trial reports and clinical development, and CDISC datasets for regulatory submission.Minimum Requirements
A bachelor’s degree in statistics, mathematics, or equivalent with at least 10 years of experience in the pharmaceutical or bio-pharmaceutical industry or a master’s degree with at least 7 years in statistics or computer science is preferred.Demonstrated good verbal and written communication skills and interpersonal skills.Self-motivated, with initiative and the ability to take ownership of, and follow through with, specific tasks.Ability to multi-task and shift priorities quickly while working under tight deadlines.New hires based in the US will be required to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption or accommodation to this vaccination requirement, subject to applicable law.Estimated salary: 160-175K/year.A note to recruiters:
We do not allow external search party solicitation. Presentation of candidates without written permission from the Ascendis Pharma Inc Human Resources team (specifically from: Talent Acquisition Partner or Human Resources Director) is not allowed. If this occurs your ownership of these candidates will not be acknowledged.Benefits
Medical insuranceVision insuranceDental insurance401(k)Paid maternity leavePaid paternity leaveCommuter benefitsDisability insurance
#J-18808-Ljbffr