455 Mission Bay Blvd. (South) San Francisco, California 94158 | Contract
Our client is a clinical-stage biopharmaceutical company developing a pipeline of drug candidates which are designed to improve the benefits of drugs for patients.
- Provides statistical input into Phase I - IV clinical trial development.
- Designs and analyzes clinical trials.
- Maintains the statistical and analytical integrity of clinical trials analyzed.
- Participates in writing statistical sections of protocols, preparing statistical analysis plans, preparing data deliverables for clinical study reports, and interpreting statistical results for clinical study reports.
- Acts as the lead statistician on clinical research projects and help with SAS programming.
- Provides statistical expertise for study design of clinical trial protocols.
- Writes statistical methods section of the study protocol.
- Develops statistical analysis plans ensuring appropriate regulatory requirements and study objectives defined in the study protocol are followed.
- Performs all analyses defined in the statistical analysis plan as well as any post-hoc analyses and relevant exploratory analyses of clinical trial data. Performs validation of statistical results.
- Provides input to key sections of clinical study reports and various regulatory documents.
- A minimum of 8 years experience in the Pharmaceutical, Medical Products industry, pharmaceutical product development or pharmaceutical formulations development is required.
- Excellent analytical skills with the ability to process scientific and medical data is required.
- Must be able to work independently and in teams.
- Must have a thorough knowledge of SAS software.
- Must have demonstrated problem solving abilities.
- Strong organizational skills are required.
- Strong written and verbal communication skills are required.
- Must have demonstrated good interpersonal skills.
- Familiarity with clinical trial design and analysis activities and basic knowledge of regulatory guidelines (FDA/CFR, ICH/GCP).
- A minimum of a Masters in a statistics discipline is required.
- A PhD degree in a statistics discipline is preferred.
- Equivalent experience may be accepted.