Senior Statistical Analyst

Role Summary

Senior Statistical Analyst will lead at least one study independently, including statistical programming and verification of Clinical Trial Data to produce high quality deliverables in a fast-paced environment. The role requires meeting study timelines and quality standards, with close collaboration and effective communication with internal teams, Statisticians, and other functional groups. There is potential to grow into a management role based on time management, leadership, and organizational skills.

Responsibilities

• Provide Statistical Programming support through production or verification of SAS scripts and outputs for Analysis Files, Tables, Listings, Figures, and other Clinical Trial deliverables, in addition to writing analysis file specifications and 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 via biometric QC of documents with clinical data.
• Provide programming support for deliverables such as Investigator Brochures, publications, regulatory submissions (US and ex-US), including CDISC compliant datasets (SDTM, ADaM) and data documentation, Reviewer’s Guide, TLFs, and 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.
• Conduct Verification Review of Statistical Analysis Plans (SAP), documents, spreadsheets, slides for in-house presentations and external publications.

Qualifications

• Required: MS, BS/BA degree, or other suitable qualification with relevance to the field.
• Required: At least 8–10 years of statistical programming experience with clinical trial data using SAS software.
• Required: A fast learner with a demonstrable record of teamwork.
• Required: Thrives in a collaborative team setting and is driven to deploy and/or adopt innovative approaches and technologies in a high-energy environment.
• Required: Excellent written and verbal communication skills.
• Required: Demonstrated ability to multi-task, prioritize options, anticipate challenges, and execute goals as a member of an interdisciplinary team.
• Required: Industry experience is essential.
• Preferred: Oncology experience is preferred.
• Preferred: Experience with managing vendors is a plus.

Education

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