Emmes Group is hiring a Senior Statistical Programmer – Contractor for its Biometrics/Biostatistics team in Bengaluru, India. The role focuses on statistical programming, validation, clinical trial datasets, statistical outputs, and regulatory submission support.
The position requires strong SAS programming skills and in-depth knowledge of CDISC SDTM and ADaM standards, along with experience in pharmaceutical, biotechnology, or CRO environments.
Job Details
| Job Detail | Information |
|---|---|
| Company | Emmes Group |
| Position | Senior Statistical Programmer |
| Job Type | Contract |
| Location | Bengaluru, India |
| Department | Biometrics/Biostatistics |
| Experience | 4–6 years |
| Qualification | Bachelor’s Degree required; Master’s Degree preferred |
| Job Reference | 3448 |
Position: Senior Statistical Programmer
The Senior Statistical Programmer will be responsible for programming, validating, and delivering statistical datasets and outputs for clinical trial analysis and regulatory submissions. The role involves collaboration with Biostatistics, Data Management, Clinical, and Regulatory teams.
Responsibilities
Programming & Validation
- Develop, test, and validate SDTM and ADaM datasets according to CDISC standards.
- Program Tables, Listings, and Figures (TLFs) for clinical study reports and regulatory submissions.
- Translate Statistical Analysis Plans (SAPs) into accurate and efficient programming code.
Project Support
- Serve as the lead programmer on individual studies or studies within a program.
- Collaborate with Biostatisticians, Clinical Data Managers, and Regulatory personnel.
- Deliver programming outputs accurately and within clinical project timelines.
Quality & Compliance
- Conduct independent quality checks on programming outputs.
- Maintain programming documentation according to internal SOPs and regulatory guidelines.
- Ensure compliance with GCP, ICH, and 21 CFR Part 11 standards.
Process Improvement
- Contribute to internal programming standards, macros, and reusable code libraries.
- Identify opportunities to optimize workflows and improve programming efficiency.
- Perform other duties as assigned and comply with company policies and standards.
Eligibility & Qualifications
Candidates should meet the following requirements:
- Bachelor’s Degree in Computer Science, Statistics, Mathematics, Life Sciences, or a related field — required.
- Master’s Degree in Computer Science, Statistics, Mathematics, Life Sciences, or a related field — preferred.
- 4–6 years of experience as a statistical programmer in a pharmaceutical, biotechnology, or CRO environment.
- Experience supporting clinical trial reporting and preparing data for regulatory submissions to agencies such as FDA and EMA.
Required Skills
- Strong SAS programming skills, including:
- Base SAS
- SAS Macro
- SAS SQL
- In-depth knowledge of CDISC SDTM and ADaM standards.
- R or Python familiarity is a plus.
- Strong attention to detail.
- Problem-solving skills.
- Effective communication skills.
- Ability to work independently and collaboratively in a fast-paced environment.
Application Details
