Associate Director, Statistical Programing

Role Summary

The Associate Director, Statistical Programmer will be responsible for performing data and statistical analysis in multiple clinical studies and collaborating with study statistician, data managers and other functions in the clinical study team. In this role you will provide technical guidance on clinical project teams. Work is performed on the design, development, and quality control process for SAS programs used to access, extract, transform, review, analyze, and submit clinical data for individual studies. In addition, you will participate in departmental and cross functional technology development and process improvement initiatives.

Responsibilities

• Lead study programmer to support activities including review SAP, set up mock TFL, dry run, draft and final TFLs
• Collaborate with other functions for requirements such as safety updates, publications, etc.
• Design and develop SAS programs including macros for efficiency and consistency
• May involve standardization and process improvement initiatives
• Support FDA submissions as needed
• Code complex SAS programs (including Macro language, SAS/STAT and SAS/GRAPH) for applications to analyze and report complex clinical trial data and for electronic review, exchange, transformation, and submission of data in CDISC SDTM format
• Perform quality control checks of SAS code and output produced by other Statistical Programmers
• Demonstrate proficient knowledge of clinical development and medical data
• Solve clinical trial reporting problems and provide technical proficiency in supporting daily operations with limited supervision
• Create CDISC data sets by transforming various raw data sources (EDC databases, IWRS), tables, figures, and listings for reporting and submitting trial results
• Work with coding dictionaries (MedDRA and WHODD) commonly used in the pharmaceutical industry
• Provide technical leadership in a team environment while solving trial reporting problems within budget and timelines and maintaining high quality

Qualifications

• Master's degree in Statistics, Mathematics, Computer Science or equivalent
• Minimum 8 years of SAS programming experience in a pharmaceutical, biotech, or CRO setting
• Strong knowledge of CDISC, including SDTM, ADaM, metadata, controlled terminologies, and data flows, and industry standards for electronic submission to FDA
• Strong hands-on SAS programming skills with experience in clinical trial reporting
• Ability to manage multiple development programs simultaneously
• Flexibility and ability to adapt quickly to changing organizational needs
• Strong interpersonal and effective communication skills (oral and written)