Contract Statistical Programmer (Fully Remote)

Iovance Biotherapeutics; Deutschland; Remote; EUR 65.000 - 100.000; Vollzeit

Zusammenfassung

Iovance Biotherapeutics in Germany is seeking a skilled SAS/R programmer to develop, validate, and maintain analyses for SDTM/ADaM datasets and safety summaries.

You will support regulatory submissions while ensuring compliance with FDA 21 CFR Part 11 and GxP. Remote collaboration with biostatisticians and clinical teams is encouraged in this fast-paced biotech environment.

Qualifikationen

• Master's degree in a quantitative field with 5+ years experience, or bachelor's with 8+ years.
• Strong proficiency in SAS and/or R for clinical trial data analysis.
• Working knowledge of CDISC standards and regulatory submission requirements.
• This role operates in a professional office or remote work environment.
• Employees are expected to maintain a safe, distraction-free workspace.
• Remote collaboration with biostatisticians, data managers, and clinical teams.

Aufgaben

• Develop, validate, and maintain SAS and/or R programs for SDTM, ADaM datasets, and TLFs.
• Support statistical analyses for safety reports, publications, and regulatory submissions.
• Ensure compliance with FDA 21 CFR Part 11, GxP, and internal SOPs.

Kenntnisse

Statistical analysis

Regulatory compliance

Team collaboration

Ausbildung

Master's degree in a quantitative field

Bachelor's degree with 8+ years experience

Tools

SAS

R

CDISC

Jobbeschreibung

• Develop, validate, and maintain SAS and/or R programs for SDTM, ADaM datasets, and TLFs.
• Support statistical analyses for safety reports, publications, and regulatory submissions.
• Ensure compliance with FDA 21 CFR Part 11, GxP, and internal SOPs.

Qualifications:

• Master's degree in a quantitative field with 5+ years experience, or bachelor's with 8+ years.
• Strong proficiency in SAS and/or R for clinical trial data analysis.
• Working knowledge of CDISC standards and regulatory submission requirements.
• This role operates in a professional office or remote work environment.
• Employees are expected to maintain a safe, distraction-free workspace.
• Remote collaboration with biostatisticians, data managers, and clinical teams.

Iovance Biotherapeutics

Iovance Biotherapeutics is a global leader in innovating, developing, and delivering tumor infiltrating lymphocyte (TIL) therapy for cancer. The company is a fast-paced biotech with a collaborative culture, committed to continuous innovation in cell therapy.