1. Principle Biostatistician
Under the direction of Director of Biostatistics, the qualified candidate will be responsible for providing optimal strategy for clinical drug development programs in a written clinical development plan, establish individual clinical study plan synopses, establish and ensure the use of standards for analysis and reporting of clinical study data. In particular, this individual will provide statistical input for pharmacokinetics/ pharmacodynamic data analysis including bioequivalence and bioavailability evaluation, population and Bayesian analysis, clinical trial design, and/or general pharmacokinetic statistical analysis.
Additional responsibilities will be to provide statistical input in design, execution, and interpretation of clinical results especially statistically valid criteria for safety and efficacy assessment; prepare reports and documentation to support applications for regulatory agency filings; coordinate with drug discovery, pre-clinical, therapeutics, toxicology, formulations research, clinical, and regulatory departments on special projects; and manage outside collaborations with other companies and CRO's.
Ph.D. with 4-8 years of pharmaceutical industrial experience or Masters degree with 6-10 years of pharmaceutical industrial experience along with solid understanding of the physiology of drug absorption, metabolism and pharmacokinetics. Experience in clinical pharmacology, pharmacokinetics and pharmacodynamics in a project team setting is essential. Candidates will be experienced in the use of SAS and conversant with statistical issues associated with phase I-IV study design and interpretation. Proficiency with statistical and pharmacokinetic software for data analysis and word processing/spreadsheet/graphing applications. Familiarity with in vivo and in vitro absorption models, bioanalyitical techniques, and PK/PD modeling is a plus. Strong communication skills and a background and experience in PK/PD modeling with WinNonlin/NONLIN are a plus.
2. Clinical Data Manager
As the Clinical Data Manager you will have three primary areas of responsibility:
- Manage CRO data management activities: coordinate the development of study data management plans and edit checks, including specifying variable parameters to ensure consistency between studies, oversee the status of query resolution during the progress of a study, and manage the transfer of interim and final database transfers from CROs.
- Verify data quality: develop data quality standards and SAS programs to assess clinical study data quality; check data quality of ongoing trials as well as execute data checks on final study data prior to database data lock.
- Support web-based clinical trials: specify variable parameters and edit specifications for trials which use web- based site data capture systems; perform pre-production system testing for each trial; monitor the system during a trial: if such a system is licensed by CVT, this position will be responsible for actually performing and/or managing the tasks of creating clinical trial electronic CRFs and electronic CRF edit checks, training, documentation, and validation.
Other responsibilities will be to review and maintenance of SAS programs, which manage WHO-DD, COSTART, and MedDRA coding; review CRFs for content, layout, and appropriate consistency with previous forms.
MS or BS degree in a technical or scientific area and at least 4 years in Clinical Data Management. Knowledge of clinical trial data and SAS programming and a basic knowledge of SQL. Fundamental knowledge of Adverse Event and Medication coding dictionaries. Must be organized and able to carefully document work; good communication skills; desire to work in a dynamic environment. Working knowledge of the PC platform (Windows 95, 98, or NT).
If you are interested in any of the above two positions, please e-mail your resume or CV to firstname.lastname@example.org