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Manager, Statistical Programming

United States – RemoteClinical Development & Clinical OperationsRegular
sich bewerben

Arbeitsbeschreibung

Serves as a project lead to provide oversight on multiple outsourced aggregated product level safety analyses projects. Acts as a fluent programmer in sophisticated Clinical Safety Surveillance analyses projects. Independently identifies issues in the analysis and assures project quality consistency. Acts as a stakeholder in multi-functional discussion on project scope, milestone, and project timeline negotiation.

Project Involvement

  • Acts as lead programmer for multiple projects.

  • May serves as project leader.

  • Overseeing vendor project activities and deliverables

Key Differentiating Contribution

  • Generates or oversees the production of statistical output (e.g., tables, listings) for aggregated compound level safety projects.

  • Actively share experiences and discuss possible process enhancements at programming meetings.

  • Recommends potential trainings.

  • Independently identifies issues in the analysis from previous experience and knowledge.

  • Provides consistency and quality assurance across various studies.

Promotional Criteria

  • A promotion from this position may be recognition for sustained performance and high potential.

  • Demonstrates strong project management skills including ability to anticipate time, resources and staffing required to successfully complete multiple projects.

Training and Development Opportunity

  • Attend a conference or class related to SAS, eCTD, CDISC, project management training.

Job Responsibility and Skills

  • Works collaboratively with Clinical Development staff to meet project deliverables and timelines for statistical data analysis and reporting.

  • Generates or oversees the production of programming deliverables (e.g., tables, listings) for safety analysis reports and to support process improvement initiatives.

  • Exhibits strong statistical & programming knowledge & expertise to influence key decisions on statistical programming outputs and provide guidance to statistical programmers.

  • Ensures programming and corresponding documentation is completed in a manner that is consistent with departmental procedures.

  • Must be able to lead and manage multiple concurrent projects.

  • Excellent verbal and written communication skills and interpersonal skills are required.

  • Has a thorough understanding of clinical trials design and reporting process.

  • Knowledge of clinical safety (DSUR/PSUR, IB RSI, RMP, CSS) reporting requirements is a plus.

  • Has the ability to resolve study related issues and conflicts within a therapeutic project.

  • Can create buy-in and has the ability to negotiate timelines.

  • Uses internal macros or writes SAS® macros to automate deliverables.

  • Responsible for harmonizing source data across multiple studies, creation and validation of Analysis Datasets and TLFs for all safety deliverables following department standards.

  • Analyze vendor performance through assessment of Key Performance and Quality Indicators (e.g. KPI, KQI), metrics, and results.

  • Serves as the point-of-contact with vendors, and liaisons with other functions.

  • Understanding of CDISC Standards (SDTM and ADaM).

Minimum Qualifications:

  • 6 years of experience and a BS degree in Biostatistics/Computer Science or equivalent.

OR

  • 4 years of experience and a MS degree in Biostatistics/Computer Science or equivalent.