Job Descriptions

Senior/Principal Statistical Programmer

Position Summary

CRC Oncology is recruiting a bilingual (EN/CN) Senior or Principal Statistical Programmer, who will provide technical expertise for the conduct of clinical trials, might act as an internal subject matter expert in specific areas providing technical support and expert advice, and works independently to support various programming activities related to the analysis and reporting of clinical study data. In addition, liaise with sponsors, Data Operations Leads, and other functional areas as required. In addition, the Principal Statistical Programmer can fill the Primary Statistical Programmer role on projects and liaise with sponsors, Data Operations Leads, and other functional areas as required. Furthermore, the Principal Statistical Programmer will monitor quality, timelines, resource allocation, and productivity in relation to budgets.

Job Responsibilities

• Input into and negotiate statistical programming timelines. Ensure that timelines are adhered to
• Lead a statistical programming team to successful completion of a study within given timelines and budget
• Monitor project resourcing, project budgets, and identify changes in scope
• Interact with Sponsors as the key contact with regards to statistical programming issues
• Provide technical support and advice to the internal team
• Check own work in an ongoing way to ensure first-time quality
• Ensure quality control (QC) on all process and technical activities related to derived dataset, table, listing, and figure programming in accordance with corporate quality standards, WSOPs/Guidelines, ICH-GCP and/or other international regulatory requirements are performed.

Qualifications

• Knowledge of the programming and reporting process
• At least 8 years of Statistical Programming experience for a Principal level role and 5+ years of experience for a Senior level role
• 5 plus years of proficiency in SAS programming
• 2+ years of ADaM, CDISC or SDTM
• Knowledge of WSOPs/Guidelines/System Life Cycle methodologies, ICH-GCP and any other applicable local and international regulations such as 21 CFR Part 11 and proven practical application
• Strong leadership ability with proven lead experience in a Pharma setting
• Demonstrate strong organizational skills, ability to manage competing priorities, and be flexible to change
• Attention to detail and excellent analytical skills
• Excellent communication skills (verbal and written)
• Competent in written and oral English and Chinese
• Excellent communication skills
• Master’s degree required, PhD Degree preferred (biological science, pharmacy or other health related discipline preferred) or relevant clinical or business equivalent and/or equivalent work experience

Seniority Level

Mid-Senior level

Industry

• Research
• Pharmaceuticals

Employment Type

Full-time

Job Functions

• Clinical Research, Statistical Analysis