Principal Statistical Programmer

Role Summary

The Statistical Programmer is a key member of Ocugen’s clinical operations team. This role provides statistical programming services including development of macros, creation of analytical datasets from raw data, and implementation of advanced statistical methods. The individual will ensure accurate, reproducible results through error-free programming in SAS, R, and other languages, collaborating with the Head of Biometrics, Head of Clinical Operations, the rest of the Ocugen team, and CROs to meet the statistical and data needs of clinical studies.

Responsibilities

• Ensures the accurate programming of data extracts and data displays
• Develops Macro repository for creation of datasets, conducting analyses, and formatting results into TFLs
• Develops programming specifications, including analysis datasets and tables/listings/figures
• Extracts, imports and formats raw datasets from EDC and other sources into SAS
• Creates CDISC compliant datasets, including SDTM, CDASH, ADaM, and SEND with corresponding documentation, including Define-XML
• Creates TFLs for CSRs, Manuscripts, and additional reports
• Provides input on CRFs, EDC, IRT, SAPs and develops corresponding mock-ups of data displays
• Implements experimental statistical methodology into programming languages
• Ensures high quality reproduce-able data and statistical results in a timely manner
• Interface with CRO ensuring data and statistical reporting is secure and timely
• Participate in study and department meetings
• May assist in developing policies and procedures (SOPs)
• Additional tasks and projects as requested

Qualifications

• Minimum MS/MA degree in Biostatistics, Statistics, Computer Science, or a related field
• At least 5 years of experience working as a Statistical Programmer or Data Scientist
• Ability to synthesize results in graphic, oral, and written reports
• Exceptionally strong statistical programming in SAS and R
• Experience programming in other languages, such as SQL, Matlab, Python
• Experience creating macros and implementing advanced statistical techniques
• Strong knowledge of GCPs, ICH, FDA, and CDISC regulatory requirements governing clinical studies
• Experience working with raw data extracts and EDC systems
• Demonstrated attention to detail and outstanding organization skills
• Self-motivated with a commitment to high quality, on-time deliverables