Description :

About the Role :

The Statistical Programmer 2 will support George Clinical projects by performing statistical programming as directed by senior management or a George Clinical Statistician. This role includes taking the lead programmer role and mentoring junior statistical programmers.

Key Responsibilities :

- Review statistical analysis plans and mock shells for complex studies.

- Program, test, and document statistical programs for creating tables, figures, and listings (TLFs).

- Develop SDTM datasets and analysis datasets (derived datasets) for internal and external clients.

- Create metadata representations of regulatory-specific and analysis datasets.

- Conduct peer-reviews of outputs from junior statistical programmers.

- Perform programming quality control checks on source data and report issues periodically.

- Provide advanced technical expertise and independently propose project solutions.

- Act as technical lead for single complex studies or groups of studies.

- Communicate directly with internal teams and clients to clarify requirements and project timelines.

- Estimate programming scope, manage resources, and communicate project status.

- Follow established standards, SOPs, and best practices.

Technical Skills :

SAS & Statistical Programming :

- Advanced SAS programming (Base SAS, SAS Macro, SAS/STAT, SAS/GRAPH, SAS/SQL)

- SAS Enterprise Guide & SAS Studio

- Strong knowledge of CDISC standards : SDTM, ADaM, Define.xml

- Pinnacle 21 validation & compliance

- Generating TLFs (Tables, Listings & Figures)

- SAS transport files (XPT format)

Clinical Data & Regulatory Standards :

- ICHGCP and FDA/EMA regulatory guidelines

- eCTD submission requirements

- Clinical trial phases IIV knowledge

- CRF, data management systems, and query handling

Programming & Data Handling :

- SQL for data extraction & transformation

- R programming (optional)

- Version control tools (Git, SVN)

- Python for data utilities (nice-to-have)

Tools & Platforms :

- EDC platforms : Medidata Rave, Oracle Clinical, Veeva

- Jira / Confluence for project tracking and documentation

- Metadata repository systems

- Automation tools for QC and workflow optimization

Quality & Compliance :

- Strong understanding of SOPs, programming standards, and validation guidelines

- Peer code reviews

- Exposure to 21 CFR Part 11 compliant systems

Other Technical Proficiencies :

- MS Office (Excel, PowerPoint, Word)

- Ability to read and interpret statistical outputs and analysis plans

- Data visualization tools (Spotfire, JMP) optional

Education & Experience :

- BS degree in a science-related field

- Minimum 3 years of SAS programming experience in a CRO

- Minimum 3 years of experience in clinical research/statistical programming

Competencies :

- Motivated to learn and share knowledge

- Good teamwork and willingness to assist others

- Technologically proficient and detail-oriented

- Flexible and adaptable to changing priorities

Additional Requirements :

- Ability and willingness to travel

What We Offer :

- Competitive compensation package

- Hybrid or remote working options

- Career growth and global exposure

- Employee wellbeing programs