Statistician/Programmer Job at cGxPServe, New Jersey

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  • cGxPServe
  • New Jersey

Job Description

Job Description:

We are seeking a highly skilled and detail-oriented Consultant Statistician/Programmer to support Real-World Evidence (RWE) and Health Economics and Outcomes Research (HEOR) initiatives. The successful candidate will work closely with the RWE/HEOR biostatistician and will be responsible for developing, executing, and validating statistical programs using SAS and/or R to support analyses and deliverables for RWE, HEOR, and Market Access activities.

Responsibilities:

    • Collaborate with HEOR and RWE biostatisticians to provide statistical programming support across various projects.
    • Develop, validate, and maintain SAS and/or R programs to support statistical analyses and reporting activities for HEOR, RWE, and Market Access studies.
    • Generate high-quality tables, listings, and figures based on clinical trial data and other relevant data sources.
    • Perform statistical modelling and analyses as required.
    • Utilize SDTM and Adam datasets to derive analysis datasets.
    • Serve as the primary programmer on assigned projects, ensuring that programming deliverables are accurate and consistent.
    • Perform quality control (QC) on statistical programs and outputs as needed.
    • Ensure all programming activities comply with industry standards, study protocols, and statistical analysis plans (SAPs).
    • Provide input on statistical methodologies and contribute to project deliverables.
    • Maintain comprehensive documentation and audit trails for all programming activities.
    • Perform rigorous data quality checks to ensure accuracy, completeness, and consistency.

Requirements:

    • Master's degree in Statistics, Biostatistics, Mathematics, Computer Science, or a related technical discipline.
    • Minimum of 4 years of experience in clinical research, preferably within the pharmaceutical or CRO industry, with exposure to Phase I IV trials.
    • Hands-on experience with CDISC SDTM and Adam datasets.
    • Proficiency in SAS and R programming is required.
    • Strong analytical and problem-solving skills, with the ability to manage complex studies and meet deadlines.
    • Experience with statistical techniques, including longitudinal data analysis, survival analysis, and statistical modelling/simulation.
    • Familiarity with observational studies, causal inference, patient-reported outcomes (PROs), and health technology assessment (HTA).
    • Experience with indirect treatment comparisons (ITCs), such as matching-adjusted indirect comparison (MAIC), is a plus.
    • Prior experience in a similar role within the pharmaceutical industry, preferably with a focus on small molecule pharmaceuticals.

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