Job Details

The Opportunity:

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.

Required Skills, Experience and Education:

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

Specific 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.

Preferred Skills:

• Oncology experience is preferred.
• 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 Programming experience