Statistical Programming Consultant

POSITION SUMMARY:

The Statistical Programming Consultant will be the lead programmer for multiple clinical studies and collaborating with study statistician, data managers and the other functions in the clinical study team.

This will be a remote opportunity. 

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Lead all programming activities of the study including review SAP, set up mock TFL, dry run, draft and final TFLs for CSR
• Collaborate with other functions for the requirement i.e. Safety update, publications etc.
• Effectively design and develop SAS programs including micros for efficiency and consistency
• Participant in SOP and process development of the department
• Participant FDA submission which requires programming
• Work with CRO and manage their deliveries as needed

KNOWLEDGE AND SKILL REQUIREMENTS:

• A degree in Statistics, Mathematics, computer science or other equivalents.
• Minimum 5 years of SAS programming in a pharmaceutical, biotech or CRO setting.
• Strong knowledge in CDISC including SDTM, ADaM, metadata, controlled terminologies, and data flows, as well as in industry standards for electronic submission of data to FDA.