Manager, Statistical Programming

Veristat

United States

This job has been expired

Description

For more than 25 years, Veristat has built a reputation as a thoughtful partner in the clinical development and regulatory submission process. We have done so by hiring talented people who align to our core values and share a common passion for our mission driven work.

Do you value a collaborative work environment and the opportunity to truly make a difference? If so, you will feel right at home here. At Veristat, you can grow both personally and professionally, with opportunities to discuss your achievements and advance your career through quarterly feedback conversations and meaningful work.

We do things differently than large CROs and would love to have you join our Veristat team!

The Manager, Statistical Programming is responsible for the statistical programming aspects of projects for clients and project teams through management of internal staff and for maintaining optimal department processes, implementing project-specific strategies, and assisting with the development and implementation of department strategies to increase productivity and quality, while decreasing cycle times and costs.

As a Manager, Statistical Programming You Will…

  • Assist with the oversight of SAS programming personnel, including hiring, managing personnel matters, and conducting performance evaluations for relevant staff.
  • Train SAS programmers regarding applicable regulatory guidelines and programming activities, including CDISC SDTM and ADaM standards to dataset programming, creating and validating SAS programs for Dataset, Tables, Listings, and Figures following the departmental QC procedures.
  • Assist with resource allocation and with the development of business proposals related to Biostatistics and Programming.
  • Serve as the programming lead on projects, as appropriate. As a project lead, the Manager, Statistical Programming develops and maintains a close liaison with client contacts, SAS programmers, biostatisticians, and project managers to drive the programmatic aspect of project delivery.
  • Provide oversight of project-related statistical programming tasks, and performs project-related tasks, as required, including: communicating with Project Managers regarding resourcing to assure the appropriate staff is assigned to each study.
  • Provide input into Case Report Form (CRF) and Data Validation Specifications (DVS) development in all therapeutic areas; writing specifications for analysis files, consistency checks, tables, and figures; analyzing clinical trial data producing accurate results representing the outcome of the trial; and validating statistical output.
  • Provide input into statistical standard operating procedures (SOPs) and general standardization efforts within the department (e.g., statistical methodology standards, standard data presentations).
  • Participate in interactions with regulatory agencies, as required.

Experience + Requirements

  • Master’s degree in technology, statistics, pharmaceutics or another related science or mathematics field with a minimum of 5 years of SAS programming experience with clinical trial data using CDISC SDTM and ADaM implementation guidelines OR Bachelor’s with a minimum of 8 years of SAS programming experience with clinical trial data using CDISC SDTM and ADaM implementation guidelines.
  • 3 years of supervisory OR 5 years of project lead experience in a CRO required.
  • Excellent working knowledge of CDISC SDTM and ADaM Implementation Guidelines.
  • Thorough knowledge of International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines and other applicable regulatory rules and guidelines as well as of medical terminology, clinical trials, and clinical research.
  • Working knowledge of the relationship and regulatory obligation of the contract research organization (CRO) industry with pharmaceutical and biotech companies.
  • Excellent knowledge of regulatory requirements and drug development process.
  • Excellent organizational skills and verbal/written communication skills.
  • Strong communication skill set with peers, business partners, and Sponsors.
  • Strong analytical mindset.