Sr. Statistical Programmer

Location: Remote, CA based company. Pacific hours are required.

SUMMARY

A clinical-stage biotech company in the Bay area is in need of a Senior Statistical Programmer to support the team on a long-term basis. This organization is dedicated to the development of oncological therapeutics. With a growing pipeline and busy workload, and the Programming team needs more support.

This consultant must have strong oncology submissions experience and solid tumor experience. The best individuals for these opportunities will thrive in a fast-paced environment without a ton of infrastructure, be willing to wear multiple hats and have excellent communication skills, asking questions in a timely manner. They will be a part of a very experienced team and must be able to work well both independently and with the rest of the team with a high degree of independence and decision-making ability, producing high quality work.

QUALIFICATIONS & REQUIREMENTS

• 10+ years of statistical programming experience (small-mid sized sponsor company experience is preferred)
• Oncology expertise is required; preferable to have solid tumor experience and understanding of RECIST criteria
• Late phase oncology submissions experience
• Able to independently develop SAS programs and specifications (SDTM, ADaM), for use in study or other analyses
• Experience with data integration used for clinical summaries and/or creation and quality control of statistical submission components to regulatory agencies
• Experience creating and maintaining listings, tabulations, graphical summaries, and formal statistical estimates and tests.
• Excellent understanding and review of CRFs/CRF specs, protocols, etc.