The successful candidate will contribute to SCiAN's Internal STAT project teams and will support the EDC-CDM group with respect to data management activities.
We are looking for someone who has:
- B.Sc. or MSc. in Statistics (preferred) or related field
- Demonstrated experience in statistical programming (SAS preferred) in the Pharma/Biotech industry. Level 1: 0 to 2 years, Level 2: 2 to 5 years, Level 3: 5+years
- Knowledge of CDISC, SDTM and ADaM preferred
- Knowledge of FDA/ICH regulations and guidelines
- Effective written and verbal communication skills
- Cooperative, team-oriented, self-motivated and detailed-oriented
- Ability to work to right timelines with high quality standards
What you will be doing (On a project-by-project Basis):
- Develop SAS programs for reporting clinical trial data and analysis ready datasets (SDTM, ADaM, TLFs)
- Develop specifications for SDTM and ADaM datasets.
- Develop specifications for data transfers
- Perform QC activities on deliverables (SDTM, ADaM, TLFs, etc).
- Perform statistical analysis of clinical trial data using appropriate methodology, under the supervision of senior statistical staff.
- Assist in the preparation of TLF shells under the supervision of senior staff.
- Assist the EDC-CDM group with validation activities (e.g. record reconciliation, DV checks, etc.)