Statistical Programmer

5 days ago

Remote, India TruMinds Technology Inc Full time

**About the Role**

Location : Remote (India)

**Key Responsibilities**
- Develop, validate, and maintain SAS programs to generate analysis datasets (ADaM, SDTM) and TLFs for clinical trial submissions.
- Ensure programming deliverables are accurate, efficient, and compliant with CDISC standards and regulatory guidelines.
- Collaborate with Biostatistics and Data Management teams to understand study requirements and timelines.
- Participate in the development of programming standards, macros, and process improvements.
- Provide mentorship and guidance to junior programmers and review their work for quality and accuracy.
- Support regulatory submissions (FDA, EMA, PMDA) by preparing submission-ready datasets and documentation.
- Troubleshoot and resolve complex programming issues independently.

**Qualifications**
- Bachelor’s or Master’s degree in Statistics, Computer Science, Mathematics, Life Sciences, or related field.
- 9+ years of experience as a Statistical Programmer in the pharmaceutical, biotechnology, or CRO industry.
- Strong proficiency in SAS programming; knowledge of R or other statistical software is a plus.
- In-depth knowledge of CDISC SDTM and ADaM standards.
- Experience supporting Phase I-IV clinical trials and regulatory submissions.
- Excellent problem-solving, communication, and organizational skills.
- Ability to work both independently and in a team-oriented environment.

**Preferred Qualifications**
- Experience with eCTD submissions and regulatory agency interactions.
- Familiarity with oncology, rare disease, or other therapeutic areas.
- Knowledge of data visualization tools (e.g., R Shiny, Spotfire).

Pay: ₹1,200,000.00 - ₹2,500,000.00 per year

**Benefits**:

- Paid sick time
- Provident Fund

**Experience**:

- SAS: 4 years (preferred)

**Location**:

- Remote (required)

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