Job Description :
As a Biostatistician, you will provide statistical and programming support to development and clinical research projects; interact with research personnel to ascertain needs and develop appropriate design and statistical solutions. In addition, you will write statistical analysis plans (SAPs) and statistical reports for use by internal and external parties.
Responsibilities:
- Interacts with development and clinical investigators to designs clinical trials with appropriate statistical methods and adequate sample size for statistical justification of clinical utility claims
- Writes data analysis plans as needed to capture design elements and statistical methodology (including specifications for analysis files, consistency checks, tables, and figures)
- Performs data analysis and prepares statistical reports of results
- Supports preparation of material to be used in regulatory interactions and submissions
- Performs Quality Control (QC) for statistical analyses by other biostatisticians to ensure analysis quality.
- Manages statistical aspects of projects (internal or outsourced)
- Contribute to scientific articles, summarizing data collected
- Maintains expertise in state-of-the-art data manipulation and statistical analyses
- Monitors work to ensure quality, and continuously promotes high quality standard
About You: Required Education, Skills, and Experience
- Master's Degree in statistics or a related field
- A minimum of 2 years statistical analysis experience in a clinical research environment
- Proficient with programming in SAS; familiarity with S-Plus/R, Sample size calculation software (e.g., East, PASS, NQuery)
- Knowledge of CDISC data standards
- Strong ability to collaborate across departments and interact with various levels in the organization
- High attention to detail with skill in producing organized reports