Associate Director, Statistical Programming

Scorpion Therapeutics; Deutschland; Hybrid; EUR 110.000 - 170.000; Vollzeit

Zusammenfassung

Scorpion Therapeutics is seeking an Associate Director, Statistical Programming to support clinical development in rare disease therapies, primarily remote from San Diego.

You will develop programming standards, oversee analysis datasets, tables, figures, listings, and submissions; lead projects, manage external vendors, review/produce SDTM, ADaM, and Define.xml documentation; ensure quality and timely delivery of programming outputs for regulatory submissions including INDs, NDAs, and safety

Qualifikationen

• Bachelor's degree in Statistics, Computer Science, or related field.
• 8+ years in clinical SAS programming with 3–5 years in leadership roles.
• Experience with SDTM, ADaM, CDISC standards and submission support.
• Strong SAS, UNIX, Windows, and MS Office skills.
• Knowledge of drug development processes and regulatory guidelines (ICH, GCP, FDA, CHMP).

Aufgaben

• Develop programming standards, oversee analysis datasets, tables, figures, listings, and submissions.
• Lead projects, manage external vendors, review/produce SDTM, ADaM, and Define.xml documentation.
• Ensure quality and timely delivery of programming outputs for regulatory submissions (INDs, NDAs, safety reports).

Kenntnisse

Leadership

Regulatory knowledge

Ausbildung

Bachelor's degree in Statistics/CS/related field

Tools

SAS

CDISC SDTM/ADaM

UNIX

MS Office

Jobbeschreibung

Role

Associate Director, Statistical Programming supporting clinical development in rare disease therapies, primarily remote from San Diego.

Responsibilities

• develop programming standards, oversee analysis datasets, tables, figures, listings, and submissions;
• lead projects, manage external vendors, review/produce SDTM, ADaM, and Define.xml documentation;
• ensure quality and timely delivery of programming outputs for regulatory submissions including INDs, NDAs, and safety reports.

Requirements

• Bachelor's in Statistics, Computer Science, or related field;
• 8+ years in clinical SAS programming, with 3-5 years in leadership roles;
• experience with SDTM, ADaM, CDISC standards, and submission support;
• strong SAS, UNIX, Windows, and MS Office skills;
• knowledge of drug development processes and regulatory guidelines (ICH, GCP, FDA, CHMP).

Preferred

• experience with R, vendor management, and cross-functional collaboration.

HighValue

supporting global clinical trials in rare diseases, primarily Phase I-III; emphasis on regulatory compliance, data standards, and submission readiness; work involves cross-functional coordination and vendor oversight.

WorkSetup

remote, based in San Diego, with face-to-face requirements; no specific travel mentioned.