Clinical statistical programmer - Katalyst Healthcares & Life Sciences

Jersy city, NJ 07097

Responsibilities:

Provide programming support for the analysis and reporting of clinical trials, including writing, testing, and validating programs for statistical analysis.
Generate tables, listings, and figures (TLFs) based on clinical study protocols and statistical analysis plans.
Develop, modify, and maintain SAS programs for data extraction, analysis, and reporting.
Ensure programming deliverables comply with relevant regulatory and company standards (e.g., CDISC, SDTM, ADaM).
Collaborate with statisticians to ensure accurate interpretation of clinical data and to produce high-quality, validated outputs.
Perform data validation checks, support data review processes, and manage discrepancies or inconsistencies in the data.
Participate in the preparation of clinical trial documentation, including datasets and outputs for regulatory submissions.
Communicate programming results and methodologies clearly with internal teams and external stakeholders, if needed.

Requirements:

Bachelor's degree in Statistics, Computer Science, Mathematics, or related field.
7 years of experience in statistical programming within the pharmaceutical or biotechnology industry.
Proficiency in SAS programming and familiarity with other statistical software packages.
Understanding of CDISC standards including SDTM and ADaM.
Strong problem-solving skills with the ability to troubleshoot programming issues.
Excellent organizational and communication skills.
Ability to work effectively both independently and in a team-oriented environment.

Experience with clinical trial data and knowledge of regulatory submission requirements.
Familiarity with FDA/ICH guidelines and other regulatory frameworks.
Advanced proficiency in SAS and knowledge of additional programming languages such as R also need.
Strong attention to detail and the ability to manage multiple priorities in a fast-paced environment.

Source : Katalyst Healthcares & Life Sciences