Manager, Statistical Programmer - Lexington, United States - Connect Life Sciences

    Connect Life Sciences
    Connect Life Sciences Lexington, United States

    2 weeks ago

    Default job background
    Pharmaceutical / Bio-tech
    Description

    Manager, Statistical Programming. Will be working closely with their biometric and cross functional team as the lead statistical programmer responsible at the study level for one of the clinical programs. This person will work closely with their statisticians, data managers, and clinical team for timely deliveries with quality. The ideal candidate is a good communicator, collaborative, self-motivated, and forward thinking.

    Responsibilities:

    • Implementing statistical analyses using SAS and performing quality review of SAS programs and deliverables for in-house analyses as well as out-sourced programming deliverables
    • Build SAS datasets from clinical databases, external data sources, and other data sources, utilizing SDTM and ADaM guidelines.
    • Produce and/or validate tables, listings, figures, and analysis datasets in response to regulatory request, publication, and ad-hoc analyses for decision-making and insights generation
    • Ensure the accuracy and completeness of programming outputs and adhere to project timeline
    • Collaborate closely with cross-functional team to effectively address their needs under the time and resource constraints
    • Collaborate with data managers and biostatisticians on data flow and data quality
    • Demonstrate ability to effectively organize and manage multiple assignments
    • Contributing to improvement in workflow and tool development to enhance processes and capabilities in the programming team.
    • Participate in the development and/or review of study related documents
    • Ability to work effectively in a fast-paced, collaborative team environment.

    Attributes:

    • Ability to evaluate the specific needs of the team, have strong problem-solving skills and detail oriented to identify and resolve issues that arise during the data analysis
    • Strong communication skills to be able to communicate effectively with key stakeholders in the clinical team and strong project management skills with biostatistical vendors
    • Ability to promote collaboration and enhance a culture of trust and respect

    Qualifications

    • Bachelor's degree or higher in statistics, computer science, biology or a related field
    • 5+ years of experience in statistical programming in the Biotech, Pharma, Clinical Research Organizations
    • CDISC experience
    • Strong knowledge of SAS programming language and experience with SAS macros, procedures, and figures.
    • Excellent communication and interpersonal skills
    • Experience working with CROs and vendors
    • Knowledge of other programming languages such as R, Python etc. is a plus