Experienced Senior Statistician
This is an excellent opportunity to play an important role in the development of a new therapy for the treatment of human disease. You will be working closely with project statisticians and CRO statisticians as well as statistical programmers within a clinical trials environment. You will interpret Statistical Analysis Plans (SAP) to determine how to analyze and display clinical trials results to assess the safety and efficacy of a new therapy. The ideal candidate must have at least 5 years of consulting or independent contractor experience.
This is a contract to start remote position.
Essential Job Functions:
- Serves as a functional lead role and / or assists functional lead in the design, analysis, and reporting of clinical and other biomedical studies.
- Writes statistical analysis plans, performs statistical analyses, contributes to and reviews study reports, and interacts with other study team members and clients on study set up (including randomization) and conduct, including timelines and financial oversight.
- Generate or quality check analysis datasets, tables, figures and listings (TFL) from clinical data, using SAS or other statistical software.
- Review protocols, statistical analysis plans and case report forms for clinical trials
- Write statistical analysis programs using SAS or other statistical software to create or verify analysis data sets and data tables, listings, and figures per specifications.
- Help draft statistical sections of study reports. Review study reports and manuscripts for accuracy.
- Provide ad-hoc analysis programming to explore repository databases and to support publications
- Responsible for accuracy of analysis datasets, statistical tables and data listings, and accuracy of report text.
- Ensure implementation of corporate standardized programming conventions and working guidance
Education / Professional experience:
- PhD or equivalent degree in statistics/biostatistics or related discipline with a minimum of 5 years relevant work experience, OR a Master's degree in statistics/biostatistics or related discipline with a minimum of 8 years relevant work experience.
Skills & competencies:
- Excellent SAS programming skills required with proficiency in SAS/Base, SAS Macros, SAS/Stat and SAS/Graph.
- Good knowledge of CDISC-compliant SAS data structures and other related regulatory guidance, i.e. SDTM, ADaM, MedDRA and WHO DRUG in programming with clinical trial data and developing programs, testing, and documentation.
- Knowledge of bio statistical methods for observational and randomized studies.
- Knowledge of statistical software packages, particularly SAS.
- Ability to think logically and systematically with careful attention to detail.
- Strong quantitative, verbal, writing and organizational skills.
- Ability to handle multiple projects concurrently.
This job description summarizes the main duties of the job. It neither prescribes nor restricts the exact tasks that may be assigned to carry out these duties. This document should not be construed in any way to represent a contract of employment.
Princeton Pharmatech is a specialized provider of biostatistics and programming solutions to the pharmaceutical , biotechnology, life science industries and research institutions worldwide. With headquarters in Princeton, New Jersey and San Francisco, CA. We have provided biostatistics and programming solutions in various therapeutic areas leading to IND and NDA submissions in the US, Europe and Japan.
We are growing and we are looking to add highly skilled and dynamic individuals to our team who are passionate about improving the quality of life of patients worldwide. Please submit your resume or CV for immediate consideration.
Sun, 2 Jul 2017 14:43:32 PDT