Senior Statistical Programmer; Direct Hire – San Diego, CA

The Senior Statistical Programmer will lead statistical programming support to major clinical studies, including ad hoc analysis for clinical development, drug safety, regulatory affair, medical affair, and research group. He/she will be working with CROs to ensure projects meet agree upon timeline with good quality, developing ISS/ISE, converting legacy study data to CDISC for submission, and validating CROs’ deliverables.

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:
These may include but are not limited to:
• Lead statistical programming activities for a major clinical study.
• Working closely with CROs, ensure agreed upon study timeline is meet with good quality of deliverables; validate CRO deliverables when needed
• Act as the statistical programming lead in cross-functional reviews of Protocols, eCRF, SAP, TFL shell, Edit check spec, and Data transfer agreements
• Participate in EDC User acceptance tests
• Program and validate ad hoc analysis requests
• Identify potential data issues affecting the quality of programming deliverables
• Contribute statistical programming and industry expertise to SOP development and in-house programming standards development

ADDITIONAL FUNCTIONS AND RESPONSIBILITIES:
• Other duties as assigned

EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES:
• A minimum of a Bachelor’s degree in related field with at least 5 years’ hands-on industry experience (an equivalent combination of education and experience may be considered)
• Strong SAS skills, including data manipulation in data step, SQL
• Proven hands-on report writing skills with SAS ODS
• Excellent working knowledge of clinical trial and drug development
• Working knowledge of industry standards, FDA and ICH guideline
• Excellent analytical, critical thinking, writing, and communication skills
• Demonstrated hands-on experience with CDISC STDM/ADaM models and define document preferred
• Oncology experience preferred