Data Sciences Staffing Solutions (DSSS) is looking to solve the problem of providing statistical support for drug development programs in all phases of development for world class pharmaceutical and biotech companies
Requirements
- PhD in Statistics, Biostatistics, or related field with 3+ years industry experience.
- MS in Statistics, Biostatistics, or related field with 5+ years of industry experience.
- Ability to use SAS and/or R to perform efficacy analyses and validate important data derivations when necessary.
- Experience with simulations.
- Understanding of ICH GCP as well as general knowledge of industry practices and standards.
- Familiarity with R programming language and other statistical software, including EAST.
- Experience with CDISC, including SDTM, ADaM, CDASH.
Responsibilities
- Validate Statistical outputs and datasets.
- Provide statistical input to study protocols.
- Writes the statistical sections of clinical trial protocols, while consulting with internal and external experts.
- Write statistical analysis plans.
- Monitor internal and CRO project activities including timelines, deliverables, and availability of resources.
- Collaborates with Data Management, Clinical Development, and Clinical Operations on design of eCRFs.
- Contributes to clinical study reports and other regulatory documents e.g., DSURs, Briefing Documents, etc.
Other
- PhD in Statistics, Biostatistics, or related field with 3+ years industry experience.
- MS in Statistics, Biostatistics, or related field with 5+ years of industry experience.
- Demonstrate ability to work independently in project management and decision making.
- Able to effectively communicate his/her ideas and to manage programmers in a constructive manner.
- 1+ years with regulatory submissions
