Senior Statistical Programmer

Scorpion Therapeutics; San Francisco Caballúa; Presencial; MXN 1,221,000 - 1,571,000; Jornada completa

Descripción de la vacante

A leading biotechnology firm is looking for a Senior Statistical Programmer to manage statistical programming deliverables for late-phase clinical trials, particularly in oncology. The role requires strong SAS programming skills, a bachelor’s degree, and a deep understanding of regulatory requirements. You will validate CRO deliverables, lead statistical programming for submissions, and collaborate with cross-functional teams. This opportunity allows for approximately 10% travel and the chance to contribute to patient care in breast cancer.

Formación

• Thorough understanding of clinical trial reporting and regulatory requirements.
• Knowledge of SDTM/ADaM specifications and programming.
• Experience with regulatory guidelines compliance.
• Oncology trial experience preferred.

Responsabilidades

• Validate and ensure quality of CRO deliverables.
• Program statistical deliverables and ensure compliance.
• Review and take ownership of study-related documents.
• Lead programming activities for regulatory submissions.

Conocimientos

SAS programming

ADaM datasets production

Strong analytical skills

Effective communication

Collaborative skills

Educación

Bachelor's degree

Advanced degree (MS, PharmD, PhD)

Descripción del empleo

Role Summary

Senior Statistical Programmer reporting to the Principal Statistical Programmer, accountable for all assigned statistical programming deliverables in adherence to company SOPs and ICH/GCP. Opportunity to work on late phase trials and contribute to patient care in breast cancer. Based in San Francisco with approximately 10% travel.

Responsibilities

• Conduct hands‑on validation/QC of CRO deliverables to ensure high‑quality SDTMs, ADaMs, and TFLs, and ensure accuracy of clinical trial results for internal and external audiences
• Conduct hands‑on programming of deliverables including IDMC meetings, DSUR, IB safety data review, Board meetings, Exploratory Analysis, and Safety Detection
• Ensure all relevant deliverables (investigator brochures, publications, all regulatory submissions with SDTM/ADaM compliance, supporting documentation such as define.xml, reviewer’s guide, and annotated CRFs) conform to SOPs and regulatory specifications
• Ensure timely delivery of all statistical deliverables for each study assigned
• Collaborate with study team members to negotiate timelines for statistical programming deliverables and related action items
• Follow departmental SOPs and processes for operational excellence
• Lead statistical programming activities for regulatory submissions following CDISC standards
• Review key study‑related documents including SAP, CRFs, DTS/DTA, and data management plan
• Take ownership for the completion of SDTM and ADaM specifications for assigned studies

Qualifications

• Required: Bachelor’s degree; advanced degree (MS, PharmD, PhD) preferred
• Required: Thorough understanding of the clinical trial reporting process and regulatory reporting requirements including electronic data submissions and CDISC implementation
• Required: Thorough knowledge of SDTM/ADaM specifications and programming
• Required: Knowledge and experience complying with regulatory guidelines (FDA and international agencies)
• Required: Strong SAS programming and graphics programming skills
• Preferred: Oncology trial experience; experience with R; experience with SAS Graphics; experience with BLA/NDA/sNDA submissions to FDA/EMA or other major global health authority submissions

Skills

• Strong ability to produce in‑house ADaM datasets and TFLs for CSR and other key deliverables
• Able to guide the successful completion of major programs and projects
• Strong analytical skills
• Collaborative with stakeholders across disciplines
• Proactive prioritization, adaptability, conflict resolution, and effective partnership
• Strong verbal and written communication skills
• Commitment to excellence; self‑motivated, fast learner, and capable of adapting in a fast‑paced environment
• Impeccable professional ethics, integrity, and judgment

Education

• Bachelor’s degree required; advanced degree (MS, PharmD, PhD) preferred

Additional Requirements

• Travel: ~10% travel anticipated