Senior Statistical Programmer

Redbock - an NES Fircroft company; California (MO); On-site; USD 120,000 - 180,000; Full time

Job summary

Redbock - an NES Fircroft company in the Bay Area is seeking three Senior Statistical Programmers for a long-term engagement. This remote role works with a California-based company; Pacific hours are required.

Candidates must have oncology expertise, solid tumor experience and RECIST knowledge, 10+ years SAS programming, and Late phase oncology submissions experience. You will independently develop SDTM/ADaM programs, create listings and electronic submissions, and collaborate with a senior team

Qualifications

• Oncology expertise required; solid tumor experience and RECIST knowledge.
• 10+ years of statistical programming experience, preferably in late-phase oncology.
• Proficient in developing SAS programs and specifications (SDTM/ADaM).
• Experience with data integration for clinical summaries and regulatory submissions.
• Experience creating listings, tabulations, graphs, and statistical estimates.

Responsibilities

• Develop SDTM/ADaM SAS programs for studies and analyses.
• Create and maintain listings, tables, listings, and figures for submissions.
• Review CRFs, CRF specs, and study protocols.
• Collaborate with cross-functional teams to ensure timely deliverables.
• Support regulatory submissions for oncology programs.

Skills

Oncology expertise

RECIST knowledge

SAS programming

SDTM/ADaM

Data listings & summaries

CRF understanding

Job description

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

SUMMARY

A clinical-stage biotech company in the Bay area is in need of three Senior Statistical Programmers 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.

These consultants 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:

• Oncology expertise is required; preferable to have solid tumor experience and understanding of RECIST criteria
• 10+ years of statistical programming experience (small-mid sized sponsor company experience is preferred)
• 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.