Principle Statistical Programmer

Location
Remote
Posted
May 25, 2021
Required Education
Bachelors Degree
Position Type
Contract

A principal statistical programmer provides timely support to the study team on all programming matters according to the project strategies. As an integral part of a study, the incumbent provides project leadership and programming support for processing data from clinical studies. Requirements will be identified according to a Statistical Analysis Plan and programming specifications using internal standards and guidelines. The incumbent assists in providing guidance in implementing and executing the programming and project standards. The evaluation and development of study requirements and validation plan are also in the scope of this position. Works independently to design and test program logic, coding programs, program documentation and preparation of programs. Oversees projects designed to support ongoing clinical studies requests for statistical and non-statistical analyses. Meets statistical adhoc requests of senior management. Provides documentation and consistent maintenance of code, logs, and output in a regulated environment.

  • Works independently, exercises judgment in interpreting, modifying, and adapting procedures, practices, methods, etc. in accordance with existing policies and standards for application to specific problems or tasks.
  • Strong SAS programming skills, preferably in a clinical data environment.
  • Strong understanding of relational database structure.
  • Understanding of reporting systems utilizing multiple data delivery applications.
  • Experience with implementing standardization methodology.
  • Demonstrated teamwork and interpersonal skills. Ability to problem solve. Strong verbal and written communication skills in a global environment.
  • Knowledge of pharmaceutical clinical development (i.e. understanding safety deliverables, efficacy analysis) and ability to provide programming support needs for BLA and other regulatory submissions.
  • Some experience in project management with supervision. Ability to organize and manage multiple assignments with challenging timelines for a limited number of personnel.
  • Problem solving and innovative skills that demonstrate initiative and motivation.
  • Ability to support multiple assignments with challenging timelines.
  • Familiarity with the development and execution of user requirements, validation plans, operational and performance protocols.
  • Knowledge in creation of current CDISC data structures.
  • Support and/or lead programmer for programming and QC of analysis datasets, TFL's or standard tools following standard data models or user requirements. Assist in the coordination of activities and communicate shifting timelines and milestones.
  • Integration of data across studies in support of CSS/CSE. Create, manage and maintain the programming specifications for the analysis datasets utilizing tools and methodologies.
  • Support creation and validation of esubmission requirements (i.e. annotated CRF, data export files, define documents).
  • Work in a multidisciplinary study team to provide timely and quality support for analysis and reporting of clinical trials up to regulatory approval, product launch and annual reprots,. If applicable, develop and provide department training for applications and standard tools developed by the department functions group.
  • Provide programming support for simple presentations and basic statistical ad-hoc requests. Assist in the more complex data presentations.
  • Participate in department working groups; provide input in development of tools and improvement of processes.
  • Adheres all direct reports about the procedures surrounding retention of data, records, and information for employees in their group.