Offer summary

Qualifications:

Proficiency in Base SAS, SAS/STAT, and SAS Macro language., 5-7 years of experience in a biotech, pharmaceutical company, or CRA/CRO., Experience with STDM and ADaM datasets, tables, listings, and figures is preferable., Excellent verbal and written communication skills..

Key responsabilities:

Contribute to the preparation of analysis plans.

Prepare, document, and test programs and data displays for clinical reports.

Ensure analysis data and programming code meet regulatory standards.

Perform quality assurance procedures on work performed by others.

Katalyst Healthcare's & Life Sciences (Katalyst HLS) is a Global Contract Research Organisation that provides End-to-End Clinical Research Services for Healthcare and Life Sciences companies globally. At Katalyst HLS offers ICH-GCP compliant clinical trial services from Phase I–IV in all key therapeutic areas to support clinical development and research requirements and also provides validation, quality and regulatory services for Pharma/Bio-Pharma/Medical Device industries. Services:- Clinical Trial Management- Clinical Data Management- Biostatistics & Statistical Programming- Medical Writing- Pharmacovigilance- Quality and Regulatory Affairs- GMP, GLP and GCP Validations- Manufacturing Process Validations- Equipments & Instruments Validations- Computer Systems Validations- Human Resourcing

Job description

Responsibilities:

Contribute to the preparation of analysis plans.
Prepare, document and test required programs and procedure data displays in an efficient manner for inclusion in integrated clinical, statistical reports and other similar reports.
Contribute to the integrated clinical/statistical report and other similar documents.
Ensure analysis data and programming code meet regulatory and company standards and are consistently structured to permit efficient programming and reporting.
Perform quality assurance procedures on work performed by others.
Develop, test, validate, document, maintain and execute software and/or systems using the currently endorsed tools or support of production activities.
Assist in the integration of data from remote entry sites.

Requirements:

Proficiency in Base SAS, SAS/STAT and SAS Macro language.
Demonstrated ability to work in teams to deliver critical milestones.
Experience with STDM and ADaM datasets, tables, listings and figures preferable.
Excellent verbal and written communication skills.
5-7 years of experience with a biotech, pharmaceutical company, or CRA/CRO.