Statistical Programmer

Bayside Solutions; California; Hybrid; USD 140,000 - 200,000; Full time

Job summary

Bayside Solutions in Redwood City, CA is seeking an experienced Senior Statistical Programmer to lead SAS programming for analysis files, TLFs, and regulatory submissions. You will verify datasets (SDTM/ADaM), write specifications, and ensure quality in a fast-paced environment. Strong communication and teamwork are essential in collaborating with statisticians and cross-functional groups.

Qualifications

• 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.

Responsibilities

• Provide Statistical Programming support for SAS scripts and outputs for analysis files, tables, listings, figures, and other clinical trial deliverables.
• 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 via biometrics QC of documents with clinical data.
• Programming support for deliverables including CDISC datasets (SDTM, ADaM) and data documentation, Reviewer's Guide, TLFs, SAPs.
• Hands-on programming of in-house deliverables (e.g., committees, board meetings, exploratory analyses).
• Verification Review of SAPs and documents for internal and external publications.

Skills

SAS programming

Clinical trials

Data analysis

Quality control

Communication skills

Education

MS/BS in a relevant field

Tools

SAS

CDISC SDTM/ADaM

Job description

Location:

Redwood City, CA - Hybrid Role

Job Summary

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.

Duties and Responsibilities:

• 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.

Requirements and Qualifications:

• 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.

Preferred Qualifications:

• 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.

Desired Skills and Experience

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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