The Statistical Programmer will play a lead role in supporting the statistical analysis and reporting of data from clinical and nonclinical studies.
- Bachelor’s degree in Statistics, Mathematics, or Computer Science or in a related field.
- Minimum of 4 years Biotechnology/Pharmaceutical/CRO industry experience as a clinical trial SAS Programmer.
- Knowledge of Base SAS, SAS Macros, SAS/STAT, SAS/Graph, and SAS/SQL.
- Demonstrate extensive knowledge of CDISC SDTM and ADaM data structures and controlled terminology, and FDA guidances and technical conformance guides covering the electronic submission standardized study data.
- Excellent organizational skills, time management, and ability to coordinate workload and meet established deadlines.
- Excellent communication and interpersonal skills to effectively interface with others.
- NDA submission experience is a plus.
Associate Director of Quality Assurance (GCP)
The primary objective of the Assoc. Director of Quality Assurance is to insure GxP (i.e. GCP, GLP, etc.) and internal SOP compliance as required for clinical and drug development related internal processes, tools, and study records, and to monitor, measure, track and communicate nonconformance to enable appropriate corrective actions. Creation of continuous improvement processes and best practices is also required to maximize productivity and efficiency within and between functional departments.
- Bachelor’s degree and 5 to 7 years of experience in clinical research quality assurance (all aspects), with 5 or more years in systems QA with a deep understanding of flexible and value-added QA processes and implementations thereof.
- Drug development lifecycle experience is highly desired.
- Qualified candidate should possess a strong knowledge of Good Clinical Practices (FDA and ICH), a good understanding of 21CFR Part 11 with respect to clinical processes and systems, including database and eCRF validation procedures, eCTD Quality Assurance, and the ability to identify and/or resolve quality issues/discrepancies with others in a proactive, diplomatic, flexible and constructive manner.
- Ability to proactively and indirectly manage and influence in a matrix environment within TI is required as is hands-on integration with functional processes.
- Some GLP (Good Laboratory Practices) and GMP (Good Manufacturing Practices) experience is also highly desirable.
- Attention to detail as well as a crisp, clear and concise style in written and oral communications is required.
Clinical Project Manager
The primary duties of this position are to provide project management and leadership to plan, prepare and execute high quality clinical trials. Ensures that all clinical activities related to one or more clinical trials are managed effectively in support of regulatory submissions and subsequent approval of dermatological drugs and devices.
- Bachelor’s-level degree required in science/health related field. A Master’s degree is preferred.
- The candidate should have a minimum of 5 years clinical research and/or clinical project management experience.
- A thorough understanding of GCPs and FDA and ICH guidelines is essential.
- Excellent written and oral communication skills, the ability to manage multiple priorities and attention to detail are critical.