Statistical Programmer

Redwood City, CA - Hybrid Role

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.

• 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 accuracy of clinical trial results for internal and external audiences (e.g., regulatory authorities, 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 Directors meetings, Exploratory Analysis, etc.
• Verification Review of Statistical Analysis Plans (SAP), documents, spreadsheets, slides for in-house presentations, and external publications.

• MS, BS/BA degree or other suitable qualification with relevance to the field.
• Oncology experience is preferred.
• At least 8-12+ years of statistical programming experience with clinical trial data using SAS software.
• Excellent written and verbal communication skills.
• Demonstrated ability to multitask, prioritize options, anticipate challenges, and execute goals as a member of an interdisciplinary team is extremely important.
• Industry experience is essential.

• 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.

SAS statistical programming, 8-12+ years of clinical trial programming experience, biotechnology/pharmaceutical industry experience, analysis dataset specifications and documentation, tables/listings/figures (TLFs), CDISC standards (SDTM/ADaM), SAS code and output verification, biometrics quality control, Statistical Analysis Plan review, ISS/ISE and exposure-response analyses, exploratory analyses, regulatory submission support, Reviewer's Guides, Investigator Brochures and publications, programming standards compliance, timeline management, multitasking and prioritization, cross-functional collaboration, written and verbal communication, relevant degree or equivalent qualification, oncology experience preferred

Bayside Solutions, Inc. is not able to sponsor any candidates at this time. Additionally, candidates for this position must qualify as a W2 candidate.

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