Clinical Application Specialist II

Planet Pharma; Illinois; On-site; USD 80,000 - 100,000; Full time

Job summary

A global pharmaceutical company is seeking a Clinical Application Specialist II who will lead statistical programming for integrated clinical safety data sets. The ideal candidate will have a BS/MS in Computer Science or Statistics, extensive SAS programming skills, and familiarity with CDISC Standards. Responsibilities include overseeing the creation of SDTM and ADaM datasets and ensuring compliance with regulatory standards. This position promotes an inclusive work environment.

Qualifications

• Require experience in SAS programming in the pharmaceutical industry.
• Extensive experience with clinical trials and regulatory agency expectations.
• Hands-on experience in SAS programming on LINUX and macro development.

Responsibilities

• Lead statistical programming activities for clinical data sets.
• Oversee the creation and validation of SDTM, ADaM and TLFs.
• Ensure compliance with training requirements and implement process improvements.

Skills

SAS programming

CDISC Standards

Statistical analysis

Data integration

Communication

Education

BS or MS in Computer Science, Statistics, or related field

Tools

SAS

LINUX

Job description

Overview

Clinical Application Specialist II at Planet Pharma. This role is responsible for leading the statistical programming activities for development and maintenance of integrated clinical safety data sets for one or more compounds/indications or therapeutic areas. This role must effectively interface with team members from Statistics, Data Sciences, Pharmacovigilance and Patient Safety, Data Analytics, Medical Writing, Regulatory Publishing and Clinical Operations.

Responsibilities

• In-depth knowledge on CDISC Standards, SAS programming concepts and techniques appropriate to the pharmaceutical industry.
• Lead compound level data integration efforts to create pooled ADAM datasets by pooling data from multiple studies, completed and ongoing, across indications.
• Experience in ADaM specs and SAS programs development supporting ISS/ISE ADaM programming and submissions.
• Oversee and be responsible for the creation and validation of SDTM, ADaM and TLFs for CSR, ISS, and ISE following SOPs, department, and project standards.
• Experience in supporting IB, DSUR and Annual Safety Reporting deliverables.
• Ability to quickly learn internal macros, processes, and programming environment.
• Team player with excellent communication skills and experience working with statisticians, data management personnel and Pharmacovigilance stakeholders.
• Oversee and be responsible for the creation and accuracy of derivations as defined in the protocol and statistical analysis plan.
• Ensure internal consistency of output and assess consistency with other activities for the project (Pooled data vs. ISS, Study data), as applicable.
• Demonstrated ability to interpret statistical analysis plans to develop analysis data set specifications.
• Ensure all process improvements are implemented.
• Provide accurate and timely responses to requests from clients with a sense of urgency.
• Be compliant with training requirements.

Qualifications

• BS or MS in Computer Science, Statistics, or a related field with SAS programming experience in Pharmaceutical or related industry.
• Extensive experience with clinical trials, including familiarity with expectations of regulatory agencies, especially FDA and EMEA.
• Excellent working experience/skill in SDTM and ADaM datasets creation/validation.
• High degree of technical competence and excellent communication skills, both oral and written.
• Demonstrated competency and hands-on experience in SAS programming on LINUX, LINUX shell scripting, macro and utilities development.
• CO/NYC candidates might not be considered.

The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.