We are looking for a highly-motivated Biostatistician on W2 or 1099 basis. This position provides statistical support for all phases of clinical development. Specific responsibilities include writing statistical analysis plans and statistical sections of protocols, and developing SAS programs for inferential analysis.
JOB REQUIREMENTS
- Write Statistical Analysis Plans and develop table and listing shells
- Provide sample size calculations
- Quality control of randomization schedules
- Provide input into development of case report forms (CRFs)
- Generate analysis datasets, tables, figures, and listings to support the analysis of clinical trials
- Provide programming support to supplemental or exploratory analyses for regulatory agencies or any other internal and external ad-hoc requests
- Perform quality control for SAS programs and other study documents
- Provide statistical analysis and reports to Data Monitoring Committees (DMCs)
- Review outputs across programs to ensure consistency
- Prepare statistical sections of clinical study reports
- Complies with company SOPs and regulatory guidance
EDUCATION AND EXPERIENCE REQUIREMENTS:
- PhD. in statistics or biostatistics with at least 3 years or MS in statistics or biostatistics with at least 5 years experience in pharmaceutical industry
- Knowledge of industry standards, such as the ICH guidelines, 21 CFR Part 11, CDISC data structures, and FDA guidelines
SKILL AND OTHER REQUIREMENTS:
- Strong in SAS programming
- Excellent organizational skills, time management, ability to coordinate workload and meet established deadlines, and a good team player
- Excellent communication and interpersonal skills to effectively interface with others
POSITION TITLE
- Senior Biostatistician or Contractor
DURATION
- 12+ months for contractor
