Project Manager I, Clinical Reporting

Job Description

We are currently seeking a Project Manager I, Clinical Reporting to join our growing team. The Project Manager I develops and leads multiple teams of SAS programming professionals in the production programming for regulatory submissions and publications. The team may include both Navitas Data Sciences’ consultants and employees of clients. This position plays a major role in establishing Navitas Data Sciences as an industry authority on clinical reporting. Critical client deliverables and activities include business process and standards, project management, reporting database development, statistical and clinical reporting, verification, migrations, validation, overall submissions support and training.

Specific responsibilities include:

  • Manage the reporting production programming and verification for Phase I-V clinical trials, ISS, ISE, Registries, Publications, or other related regulatory submissions
  • Perform SAS programming and analysis support of the generation of analysis datasets, statistical analysis, listings, figures, and tables
  • Develop SAS application code
  • Perform validation of SAS programs and deliverables
  • Perform SDTM and ADaM mapping
  • Generate SDTM and ADaM deliverables
  • Assist in designing data presentations
  • Work directly with client managers
  • Assist the Marketing and Sales process in new business development
  • Recommend and implement improvements in reporting standards and reporting business process
  • Implement project management methodology
  • Set project priorities and timelines
  • Advise team members in the achievement of schedules and deliverables
  • Ensure that team uses client programming processes and programming environment properly
  • Interface with cross-functional team members
  • Onboard, mentor, supervise and training of staff
  • Providing budgetary input on projects
  • Implement the software products of Navitas Data Sciences
  • Train clients on vendor applications, e.g. SAS, CR Toolkit and others
  • Develop, publish and present white papers and presentations at industry conferences
  • Serve as an Expert in two or more areas that may include Project Management, SCE, SDTM, ADaM, define.xml, SAS programming, deliverables process, Tables, Graphics, PK/PD, Registries, or other areas
  • Develop and contribute to the best practices of Navitas Data Sciences
  • Lead one or more project teams at a client

Desirable Skills and Experience

  • Excellent management, interpersonal, communication, and organizational skills
  • Ability and desire to interface with senior management and executives in client engagements and industry associations
  • Working knowledge of CDISC, SDTM, and ADaM
  • Expert knowledge of SAS-based statistical programming
  • 15+ years pharmaceutical or CRO industry experience in clinical reporting and statistical programming
  • Minimum of 4 years’ project lead/project management experience managing projects and/or staff
  • Background in statistics and statistical analysis is desirable.

US - Remote

Bachelor’s Degree in Computer Science, Statistics or equivalent, Master’s degree preferred


Data Sciences

Full Time

15 Oct 2021