Associate Director, Statistical Programming

POSITION SUMMARY

This is a hybrid role - our work from home days are Monday and Friday and our in-office days are Tuesday, Wednesday and Thursday.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Work with Head of Statistical Programming to implement Statistical Programming strategies related to vendor oversight, automation, innovation in technology, processes, and standards to maximize efficiency in statistical analysis and reporting.
• Lead the development and implementation of global programming standards library to enable consistent and efficient project deliverables.
• Develop tools for efficient production and validation of derived datasets, e.g., SDTM and ADaM, and TFLs.
• Collaborate cross-functionally with teams from Clinical Development, Clinical Operations, Regulatory Affairs, and others to meet project deliverables and timelines for statistical data analysis and reporting.
• Guide and monitor CRO activities and review CRO staff & deliverables.
• Review SDTM and ADaM specifications, CRF annotations and Define.xml or Define.pdf files.
• Perform quality control for SAS programs and other study documents (e.g., presentations and reports).
• Provide statistical programming support to supplemental or exploratory analyses for regulatory agencies or any other internal and external ad-hoc requests.

Minimum Qualifications:

• Bachelors degree in Statistics, or Computer Science or in a related field preferred.
• 8+ years’ experience in clinical programming in the biotechnology pharmaceutical or health related industry
• Experience in vendor management
• Knowledge of SAS, R, or any other coding language.
• Strong coding capabilities, analytical and problem-solving skills.
• Management experience is a plus.
• Strong communication and interpersonal skills.
• Pharmaceutical/CRO industry experience as a SAS Programmer is a plus.
• CDISC SDTM/ADaM standards knowledge is a plus.
• NDA submission experience is a plus.

The anticipated annual salary range for candidates who will work in Newark, California is $190,000 - $210,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. CymaBay is a multi-state employer, and this salary range may not reflect positions that work in other states.