Associate Director, Statistical Programming
Job Location:
Job Location:
Lexington, KY - USA
Yearly Salary:
$ 188000 - 228000
Yearly Salary:
Posted on:
15 hours ago
Posted on:
Vacancies:
1 Vacancy
Vacancies:
Job Summary
Description
uniQure Inc. Associate Director Statistical Programming (Lexington MA - hybrid): Responsible for leading Statistical Programming activities including hands-on implementation of statistical analyses using SAS and quality reviews of SAS programs and deliverables for in-house analyses and outsourced programming tasks. Duties include:
Masters degree in Statistics Mathematics Computer Science or closely related scientific/medical field plus 7 years of professional experience in SAS statistical programming in clinical trial settings (industry/CRO).
Experience which may have been gained concurrently with the primary requirement above must include 7 years of experience with:
Salary is $188000 to $228000 per year for a 40-hour work week. Interested applicants should submit their resume to Jim Smith Executive Dir Total Rewards and People Ops uniQure Inc. via the following email:
This notice is being provided as a result of the filing of an application for permanent alien labor certification for this position. Any person may provide documentary evidence bearing on this application to the Certifying Officer of the Office of Foreign Labor Certification of the Department of Labor:
U.S. Department of Labor
Employment and Training Administration
Office of Foreign Labor Certification
200 Constitution Avenue NW Room N-5311
Washington DC 20210
uniQure Inc. Associate Director Statistical Programming (Lexington MA - hybrid): Responsible for leading Statistical Programming activities including hands-on implementation of statistical analyses using SAS and quality reviews of SAS programs and deliverables for in-house analyses and outsourced programming tasks. Duties include:
- Serve as the lead statistical programmer to analyze and interpret statistical data evaluate statistical modeling and designs produce and/or validate tables listings figures and analysis datasets for regulatory requests publication needs and ad-hoc analyses; write specifications for programming requirements.
- Lead the Statistical Programming group within the Biometrics Department to ensure proper data structuring data collection and tabulation.
- Develop and manage the statistical computing environment including statistical folder structure and access control.
- Collaborate with biostatisticians and clinical development colleagues to evaluate statistical methodology develop/review Tables Figures and List (TFL) shells Study Data Tabulation Models (SDTMs) and Analysis Data Model (ADaM) specifications.
- Oversee study-level programming deliverable timelines in collaboration with the study lead biostatistician and cross-functional teams and adapt statistical methods to solve problems efficiently within projected timelines.
- Manage Contract Research Organizations (CROs) and contractors ensuring compliance quality of deliverables timelines and budget adherence.
- Work closely with Data Management and Biostatistics teams to ensure the accuracy of final databases analyses and reports.
- Identify issues and develop global tools such as macros or graphical user interface applications to enhance the efficiency and capacity of the Statistical Programming group.
- Liaise between the biostatistics and clinical data management group to ensure the delivery of high-quality clinical data and serve as subject matter expert (SME) in multi-functional project teams providing strategic and technical expertise.
Masters degree in Statistics Mathematics Computer Science or closely related scientific/medical field plus 7 years of professional experience in SAS statistical programming in clinical trial settings (industry/CRO).
Experience which may have been gained concurrently with the primary requirement above must include 7 years of experience with:
- Advanced SAS programming skills including:
- Utilizing procedures and options commonly used in clinical trials
- Reporting with Macro language BASE SAS SAS/STAT and SAS/GRAPH validation/QC and generating listings tables figures.
- Working with CDISC standards including SDTM and ADaM models and implementing these standards/models in clinical trials.
- Working with regulatory guidelines (FDA EMA ICH) relevant to clinical trials statistics and data handling preparing data for submission in compliance with regulatory requirements and standards.
- Outsourcing programming activities and overseeing services provided by CROs and contractors.
- Planning and managing multiple responsibilities concurrently while maintaining high standards of quality and meeting deadlines.
Salary is $188000 to $228000 per year for a 40-hour work week. Interested applicants should submit their resume to Jim Smith Executive Dir Total Rewards and People Ops uniQure Inc. via the following email:
This notice is being provided as a result of the filing of an application for permanent alien labor certification for this position. Any person may provide documentary evidence bearing on this application to the Certifying Officer of the Office of Foreign Labor Certification of the Department of Labor:
U.S. Department of Labor
Employment and Training Administration
Office of Foreign Labor Certification
200 Constitution Avenue NW Room N-5311
Washington DC 20210
Required Experience:
Director
About Company
Join Us At uniQure, we are in a continuous search for talented, experienced, motivated people to help take us to the next level of performance across every functional area of our company. We invite you to browse the open positions on this page to find one that fits your goals and qual ... View more
