Senior Statistical Programmer – Late Stage Development – Oncology-Hybrid
| Company | Inventing for Life |
|---|---|
| Location | North Wales, PA, USA |
| Salary | $Not Provided – $Not Provided |
| Type | Full-Time |
| Degrees | Bachelor’s, Master’s |
| Experience Level | Senior, Expert or higher |
Requirements
- BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 5-9 years SAS programming experience in a clinical trial environment
- MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 3-7 years SAS programming experience in a clinical trial environment
- Effective interpersonal skills and ability to negotiate and collaborate effectively
- Effective written, oral, and presentation skills
- Effective knowledge and experience in developing analysis and reporting deliverables for R&D projects (data, analyses, tables, graphics, listings)
- Significant expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH; systems and database expertise
- Ability to comprehend analysis plans which may describe methodology to be programmed; an understanding of statistical terminology and concepts
- Familiarity with clinical data management concepts
- Experience in CDISC and ADaM standards
- Experience ensuring process compliance and deliverable quality
- Strategic thinking – ability to turn strategy into tactical activities; design of statistical databases with the end in mind that optimize analysis and reporting and leverage departmental standards and industry best-practices
- Ability to anticipate stakeholder requirements
Responsibilities
- Support statistical programming activities for late stage drug/vaccine clinical development projects
- Lead one or more projects
- Develop and execute statistical analysis and reporting deliverables (e.g. safety and efficacy analysis datasets, tables, listings, figures)
- Design and maintain statistical datasets that support multiple stakeholder groups
- Collaborate with statistics and other project stakeholders to ensure efficient execution of project plans
- Serve as the statistical programming point of contact and knowledge holder through the entire product lifecycle
- Effective analysis and report programming development and validation utilizing global and TA standards and following departmental SOPs and good programming practices
- Maintain and manage a project plan including resource forecasting
- Coordinate the activities of a global programming team that includes outsource provider staff
- Membership on departmental strategic initiative teams
Preferred Qualifications
- Demonstrated success in the assurance of deliverable quality and process compliance. Strong working knowledge of reporting processes (SOPs) and software development life-cycle (SDLC)
- US and/or worldwide drug or vaccine regulatory application submission experience including the development of electronic submission deliverables
- Experience assuring programming consistency across protocols and projects, directing the program development effort of other programmers; experience as a programming mentor
- Ability and interest to work across cultures and geographies
- Ability to complete statistical programming deliverables through the use of global outsource partner programming staff
- Experience developing and managing a project plan using Microsoft Project or similar package
- Active in professional societies
- Experience in process improvement