Associate Principal Scientist – Statistical Programmer – Oncology
| Company | Inventing for Life |
|---|---|
| Location | North Wales, PA, USA, Linden, NJ, USA |
| Salary | $135500 – $213400 |
| 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 9 years SAS programming experience in a clinical trial environment.
- MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 7 or more years SAS programming experience in a clinical trial environment.
- Excellent interpersonal skills and ability to negotiate and collaborate effectively.
- Excellent written, oral, and presentation skills.
- Broad knowledge and significant experience in developing analysis and reporting deliverables for R&D projects (data, analyses, tables, graphics, listings).
- Strong project management skills; leadership at a program level; determines approach and ensures consistency and directs development of others when opportunities arise; ability to engage key stakeholders.
- Significant expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH; systems and database expertise.
- Experience leading large and/or complex statistical programming projects that include coordinating the activities of a programming team.
- US and/or worldwide drug or vaccine regulatory application submission experience at the leadership level including the development of electronic submission deliverables.
- Designs and develops complex programming algorithms.
- 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.
- Demonstrated success in the assurance of deliverable quality and process compliance.
- 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
- 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
- Strong working knowledge of reporting processes (SOPs) and software development life cycle (SDLC).
- Experience providing technical and/or programming guidance and mentoring to colleagues.
- 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.