Sr. Statistical Programmer

Redbock - an NES Fircroft company; San Francisco (CA); On-site; USD 150,000 - 190,000; Full time

Job summary

Redbock - an NES Fircroft company in the San Francisco Bay area is seeking a Senior Statistical Programmer to support a growing oncology-focused pipeline on a long-term basis. You will develop SAS programs (SDTM/ADaM) and contribute to regulatory submissions within a fast-paced, collaborative team.

The ideal candidate has 10+ years of programming experience in oncology, solid tumor RECIST knowledge, and a proven ability to work independently while communicating clearly with cross-functional

Qualifications

• 10+ years of statistical programming experience, preferably in small to mid-sized sponsors.
• Oncology expertise with solid tumor experience and RECIST understanding.
• Experience in late-phase oncology submissions.
• Ability to independently develop SAS programs (SDTM/ADaM) for studies.
• Experience with data integration for clinical summaries and regulatory components.
• Proficiency creating listings, tabulations, graphs, and statistical estimates/tests.
• Strong review of CRFs/CRF specs, protocols, etc.

Responsibilities

• Develop SAS programs and specifications for analyses.
• Contribute to late-phase oncology submissions.
• Prepare data listings, tables, figures for regulatory documents.
• Collaborate with team and communicate findings clearly.

Skills

Statistical programming

Oncology expertise

Independent work

Communication

RECIST knowledge

Tools

SAS

SDTM/ADaM

Regulatory submissions

Job description

***Third-party company inquiries will not be entertained.***

SUMMARY:

A clinical-stage biotech company in the Bay area is in need of one 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.

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:

• 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.