Preferred Education:

• Requires Bachelor’s degree in Pharmacy, Statistics or closely related field.

Location:

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

Contact Person:

• jobsus@acldigital.com

Experience:

• BS 3 to 5 years

Roles & Responsibilities:

• Provide leadership support for the team including estimating the work hours required, providing deliverables timeline, assigning tasks to peers, reviewing the outputs, delivering the outputs to Statisticians, collaborating with other teams and providing inputs as per the study requirement.
• Review protocols, case report forms (CRF) and statistical analysis plans (SAP) for clinical trials and provide feedback to functional teams in order to fast track pre-study processes.
• Ensure analysis datasets are in compliance with CDISC and submission regulatory requirements.
• Analyze clinical data complying with CDISC standards and by implementing various statistical procedures.
• Develop, maintain, and debug complex programs within or outside an analysis and reporting system with Statistical Analysis Plan, data specifications as required.
• Programming reports for many issue-driven requests from external/internal sources, under very tight timelines.
• Performs highly complex programming to implement statistical methodologies developed by internal and external biostatisticians.
• Develop and maintain internal SAS macro library for statistical analysis and reporting. Identify, communicate, and manage study-based risks and issues.
• Review regulatory submissions data package and ensure its quality and integrity.
• Involve in the development and validation of Tables Listings & Figures (TLFs) for Integrated Sum1maries of Efficacy (ISE) and Safety (ISS) for FDA submission.
• Assess and perform statistical analysis of the chemical kinetics data, pharmacological data like Pharmacokinetics and pharmacodynamics data of drug candidates (chemical compounds) on an adhoc basis.