ACL Digital
Senior Statistical Programmer
ACL Digital, King Of Prussia, Pennsylvania, United States, 19406
Job Title: Statistical Programmer
Location:
Calsoft Labs Inc., d/b/a ACL Digital - 501 Allendale Road, Suite 201, King of Prussia, PA 19406Minimum Requirements:
Requires Bachelor’s degree in Pharmacy, Statistics or closely related field.Experience:
3 to 5 years of experience in statistical programming.Responsibilities:
Provide leadership support for the team including estimating work hours required, providing deliverables timeline, assigning tasks to peers, reviewing outputs, and delivering outputs to Statisticians.Collaborate with other teams and provide inputs as per study requirements.Review protocols, case report forms (CRF), and statistical analysis plans (SAP) for clinical trials and provide feedback to functional teams to fast track pre-study processes.Ensure analysis datasets comply with CDISC and submission regulatory requirements.Analyze clinical data in compliance with CDISC standards and implement various statistical procedures.Develop, maintain, and debug complex programs within or outside an analysis and reporting system according to the Statistical Analysis Plan and data specifications.Program reports for various issue-driven requests from external/internal sources under tight timelines.Perform highly complex programming to implement statistical methodologies developed by internal and external biostatisticians.Develop and maintain an internal SAS macro library for statistical analysis and reporting. Identify, communicate, and manage study-based risks and issues.Review regulatory submissions data packages to ensure quality and integrity.Involve in the development and validation of Tables Listings & Figures (TLFs) for Integrated Summaries of Efficacy (ISE) and Safety (ISS) for FDA submission.Assess and perform statistical analysis of chemical kinetics data, pharmacological data like Pharmacokinetics and pharmacodynamics data of drug candidates on an adhoc basis.
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Location:
Calsoft Labs Inc., d/b/a ACL Digital - 501 Allendale Road, Suite 201, King of Prussia, PA 19406Minimum Requirements:
Requires Bachelor’s degree in Pharmacy, Statistics or closely related field.Experience:
3 to 5 years of experience in statistical programming.Responsibilities:
Provide leadership support for the team including estimating work hours required, providing deliverables timeline, assigning tasks to peers, reviewing outputs, and delivering outputs to Statisticians.Collaborate with other teams and provide inputs as per study requirements.Review protocols, case report forms (CRF), and statistical analysis plans (SAP) for clinical trials and provide feedback to functional teams to fast track pre-study processes.Ensure analysis datasets comply with CDISC and submission regulatory requirements.Analyze clinical data in compliance with CDISC standards and implement various statistical procedures.Develop, maintain, and debug complex programs within or outside an analysis and reporting system according to the Statistical Analysis Plan and data specifications.Program reports for various issue-driven requests from external/internal sources under tight timelines.Perform highly complex programming to implement statistical methodologies developed by internal and external biostatisticians.Develop and maintain an internal SAS macro library for statistical analysis and reporting. Identify, communicate, and manage study-based risks and issues.Review regulatory submissions data packages to ensure quality and integrity.Involve in the development and validation of Tables Listings & Figures (TLFs) for Integrated Summaries of Efficacy (ISE) and Safety (ISS) for FDA submission.Assess and perform statistical analysis of chemical kinetics data, pharmacological data like Pharmacokinetics and pharmacodynamics data of drug candidates on an adhoc basis.
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