Note: The job is a remote job and is open to candidates in USA. Redbock is recruiting for an unnamed client seeking a Principal Statistical Analyst to support statistical programming and verification of clinical trial data. The role produces and verifies clinical-trial deliverables, supports regulatory submissions and in-house analyses, and ensures quality and timely delivery in collaboration with cross-functional teams.
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 Director meetings, Exploratory Analysis, etc
- Verification Review of Statistical Analysis Plans (SAP), documents, spreadsheets, slides for in-house presentations and external publications
Skills
- MS, BS/BA degree or other suitable qualification with relevance to the field
- At least 14+ years of statistical programming experience with clinical trial data using SAS software
- 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
- Oncology experience is preferred
- 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
Benefits
- Remote in the US
Company Overview
Company H1B Sponsorship