Senior Statistical Programmer

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.