Senior Statistical Programmer

Company:  ACL Digital
Location: King of Prussia
Closing Date: 01/11/2024
Salary: £100 - £125 Per Annum
Hours: Full Time
Type: Permanent
Job Requirements / Description

Job Title: Statistical Programmer

Location: Calsoft Labs Inc., d/b/a ACL Digital - 501 Allendale Road, Suite 201, King of Prussia, PA 19406

Minimum 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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