Summary:

• 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

• 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.)