The position of Biostatistician requires a Masters and above in biostatistics, or related field, and at least 3 years of experience working in the field of clinical drug development at a pharmaceutical, biotechnology, or contract research organization. The ideal candidate will have experience working with a variety of statistical applications, a mastery of SAS, and have expertise in the central nervous system (CNS) therapeutic area.
The primary responsibility of the Senior Biostatistician is to provide all specified biostatistics deliverables for assigned clinical trial projects. This includes development of statistical analysis plans, statistical analyses of data, production of tables, listings and figures, and delivery of statistical results in numeric and text form.
- Assume the role of Study Statistician for assigned studies.
- Preparation and review of Statistical Analysis Plans and Statistical Contributions, with appropriate guidance from other statistical staff.
- Perform power analyses and sample size calculations.
- Review of case report forms (CRFs) and related study materials.
- Statistical analysis of clinical trial data using basic methodology, with appropriate guidance from other statistical staff.
- Production of data tables and graphs to the required specification for clinical, pharmacokinetic and statistics reports.
- Preparation of randomization schedules.
- Preparation of TLFs for safety committee meetings.
- Perform QC of analysis datasets, data displays for secondary efficacy and safety variables.
- Maintain project administration files with regard to all documents produced by Biostatistics, including associated review, QC and project tracking information and internal and external communications.
- SAS programming and related activities for the presentation and analysis of clinical trial data.
- Review of protocols, clinical study reports, and other documents.
- Interaction with customers at bid defense meetings, project review meetings, and other settings.
- Education of Clinilabs Drug Development Corporation’s staff
- Bachelors required but PhD preferred in Biostatistics or related field.
- Minimum seven (7) years of experience working in the field of clinical drug development with bachelor’s degree or five (5) years of experience (transferable skills) with advanced degree. One (1) to two (2) years in a supervisory role is preferred.
- In-depth knowledge of ICH/FDA regulations regarding statistical analysis, clinical practices and other pertinent guidance.
- Excellent SAS programming skills. Knowledge of Base SAS and SAS/STAT modules is required.
- Must be able to perform and interpret the statistical results and communicate them in both written and verbal forms.
- Ability to work in a multi-disciplinary team setting.
- Computer proficient in a Microsoft Windows environment. Capable of using Microsoft Office products such as Word and Excel.
- Ability to work under tight deadlines and time constraints with rapid shifts in direction and/or priorities Excellent problem-solving skills.
- Strong attention to detail and accuracy.
- Strong commitment to quality.