Senior Statistical Programmer, FSP

Jobtailor; Deutschland; Vor Ort; EUR 80.000 - 110.000; Vollzeit

Zusammenfassung

Jobtailor is seeking an experienced SAS programmer to lead data manipulation, analysis and reporting of clinical trial data (safety and efficacy). You will generate and validate SDTM and ADaM datasets and tables, listings and figures, and produce QC/validation programming.

You will collaborate with cross‑functional teams, manage multiple projects as a study lead when needed, and support submissions with define.xml and related documents.

Qualifikationen

• Bachelor’s degree in Statistics, Computer Science, Mathematics, or related field.
• 8+ years SAS programming in clinical trial data; 6+ years with master's or higher.
• Study lead experience with multiple projects.
• Strong SAS data manipulation, analysis and reporting skills.
• Experience with CDISC SDTM/ADaM standards.
• QC/validation skills.
• Ad-hoc reporting skills.
• Proficiency in efficacy analysis.
• Experience with submissions defining define.xml.
• Experience in immunology, respiratory, or oncology studies is a plus.
• Excellent analytical & troubleshooting skills.
• Ability to deliver quality output under tight timelines.
• Experience working with globally dispersed teams.

Aufgaben

• Perform data manipulation, analysis and reporting of clinical trial data, using SAS.
• Generate and validate SDTM/ADaM datasets and TLFs.
• Produce QC/validation programming.
• Generate complex ad‑hoc reports from raw data.
• Provide clear efficacy analysis.
• Create and review submission documents and eCRTs.
• Coordinate with cross‑functional teams and clients on project specs and status.
• Lead duties when called upon.
• Be a team player, meeting deadlines.
• Stay adaptable as priorities change.

Kenntnisse

Analytical thinking

Troubleshooting

Team collaboration

Project management

Ausbildung

Bachelor’s degree in Statistics

Bachelor’s degree in Computer Science

Bachelor’s degree in Mathematics

Master’s degree or higher

Tools

SAS

Jobbeschreibung

Responsibilities

• Perform data manipulation, analysis and reporting of clinical trial data, both safety and efficacy (ISS/ISE), utilizing SAS programming
• Generate and validate SDTM and ADaM datasets/analysis files, and tables, listings, and figures (TLFs)
• Produce QC / validation programming
• Generate complex ad‑hoc reports utilizing raw data
• Apply strong understanding/experience of Efficacy analysis
• Create and review submission documents and eCRTs
• Communicate with and/or respond to internal cross‑functional teams and clients for project specifications, status, issues or inquiries
• Perform lead duties when called upon
• Serve as a team player, with a willingness to go the extra distance to get results, meet deadlines, etc.
• Be adaptable and flexible when priorities change

Requirements

• Bachelor’s degree in one of the following fields: Statistics, Computer Science, Mathematics, etc.
• At least 8 years of SAS programming working with clinical trial data in the Pharmaceutical & Biotech industry with a bachelor’s degree or equivalent. At least 6 years of related experience with a master’s degree or above.
• Study lead experience, preferably juggling multiple projects simultaneously.
• Strong SAS data manipulation, analysis and reporting skills.
• Solid experience implementing the latest CDISC SDTM / ADaM standards.
• Strong QC / validation skills.
• Good ad‑hoc reporting skills.
• Proficiency in Efficacy analysis.
• Familiarity with drug development life cycle and experience with the manipulation, analysis and reporting of clinical trials’ data.
• Submissions experience utilizing define.xml and other submission documents.
• Experience supporting immunology, respiratory or oncology studies would be a plus.
• Excellent analytical & troubleshooting skills.
• Ability to provide quality output and deliverables, in adherence with challenging timelines.
• Ability to work effectively and successfully in a globally dispersed team environment with cross‑cultural partners.