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Statistical Programming Consultant

Redwood City, CA 94063

Posted: 06/02/2023 Employment Type: Contract Job Category: Other Job Number: 568463 Is job remote?: No Country: United States

Job Description

The Opportunity:
Market Rate

This position will be responsible for statistical programming and verification of Clinical Trial Data to produce high-quality deliverables in a fast-paced environment. This person needs to consistently meet study timelines, quality standards, and requirements, and be required to work closely and communicate effectively with internal team members, Statisticians, and other functional group members to best serve the deliverable need.

Specific responsibilities:

In this position, Statistical Programmer is expected to:

  • Provide Statistical Programming support either in the form of production or verification of SAS scripts and outputs for Analysis Files, Tables, Listings, Figures, and any other form of Clinical Trial in addition to writing analysis file specifications and other relevant documentation of deliverables and analysis methods.

  • Ensure effective planning to meet quality and timely delivery of deliverables.

  • Comply with project/study programming standards and specifications following internal guidelines.

  • Ensure the accuracy of clinical trial results for internal and external audiences (e.g., regulatory authorities, the academic community, and healthcare providers) via biometrics QC of documents with clinical data.

  • Programming support for relevant deliverables, such as Investigator Brochures, publications, US and ex-US regulatory submissions, including CDISC compliant datasets (SDTM, ADaM) and data documentation, Reviewer’s Guide, TLFs, Statistical Analysis Plans (study specific, ISS, ISE, Exposure-Response).

  • Hands-on programming of in-house deliverables including but not limited to Dose Committee meetings, Board of Director meetings, Exploratory Analysis, etc.

  • Verification Review of Statistical Analysis Plans (SAP), documents, spreadsheets, and slides for in-house presentations and external publications.

Required Experience, Skills, and Education:

  • MS, BS/BA degree, or other suitable qualification with relevance to the field.

  • Oncology experience is preferred.

  • At least 6-8 years of statistical programming experience with clinical trial data using SAS software.

  • A fast learner with a demonstrable record of teamwork.

  • Thrives in a collaborative team setting and is driven by a desire to deploy and/or adopt innovative approaches and technologies in a high-energy environment.

  • Excellent written and verbal communication skills.

  • Demonstrated ability to multi-task, prioritize options, anticipate challenges, and execute goals as a member of an interdisciplinary team is extremely important.

  • Industry experience is essential.
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