Job Title: Senior Statistical Programmer

Experience: 6-10 Years

Location: Anywhere in India (Remote/Hybrid as per business requirements)

Job Summary:

We are seeking an experienced and detail-oriented Senior Statistical Programmer to join our Clinical Data Sciences team. The ideal candidate will have strong expertise in clinical trial programming, CDISC standards (SDTM and ADaM), SAS programming, and regulatory submissions. The successful candidate will play a critical role in developing and validating clinical datasets, statistical outputs, and submission packages while ensuring compliance with industry standards and regulatory guidelines.

The candidate should possess excellent analytical skills, a strong understanding of clinical trial processes, and the ability to collaborate effectively with cross-functional teams, including Biostatistics, Clinical Data Management, Medical Writing, and Regulatory Affairs.

Key Responsibilities:

1.

Clinical

Programming:

- Review and interpret study-related documents including:

1.

Clinical Study

Protocols

2.

Statistical Analysis

Plans (SAP)

3.

Case Report

Forms (CRFs)

4.

Annotated Case Report

Forms (aCRFs)

- Mock Tables, Listings, and Figures (TLFs)
- Develop, validate, and maintain SDTM datasets according to CDISC standards.
- Develop and validate ADaM datasets for efficacy and safety analyses.
- Generate and validate Tables, Listings, and Figures (TLFs) using SAS programming.
- Ensure all programming deliverables comply with study specifications and regulatory requirements.

2. Data Standards &

- Regulatory Submissions:
- Prepare and review CDISC-compliant submission packages.
- Develop and review Define.xml documentation.




- Prepare and review Reviewer Guides (Data Reviewer Guide and Analysis Data Reviewer Guide).
- Generate and validate Pinnacle 21 (P21) reports and resolve compliance issues.
- Ensure regulatory submissions meet FDA, EMA, PMDA, and other applicable health authority requirements.

3.

Statistical

Programming:

- Develop reusable SAS macros and utilities to improve programming efficiency.
- Perform quality control (QC) and validation of programming outputs.
- Independently troubleshoot programming issues and recommend appropriate solutions.
- Participate in database lock activities and final statistical reporting.
- Support interim analyses, safety reviews, and ad hoc reporting requests.

4.

Study

Management:

- Work independently on assigned clinical studies while meeting project timelines.
- Provide regular status updates to the Study Lead Programmer or Project Manager.
- Identify study risks, programming challenges, and potential delays, and proactively communicate mitigation plans.
- Participate actively in study meetings, sponsor discussions, and cross-functional team meetings.
- Serve as backup Lead Programmer when required.

5. Documentation &

- Compliance:
- Maintain complete programming documentation in accordance with Standard Operating Procedures (SOPs),



Work Instructions (WIs), and regulatory requirements.
- Ensure programming traceability throughout the clinical study lifecycle.
- Maintain version-controlled programming specifications and validation documentation.
- Follow Valuable Clinical Practice (GCP), ICH guidelines, and internal quality standards.

6.

Process

Improvement:

- Contribute to the development and enhancement of statistical programming standards, templates, and best practices.
- Develop reusable programming tools to improve quality and efficiency.
- Participate in process improvement initiatives and automation projects.
- Stay updated with evolving CDISC standards, regulatory requirements, and industry best practices.

7. Leadership &

- Mentoring:
- Mentor and provide technical guidance to junior statistical programmers.
- Review programming deliverables produced by junior team members.
- Conduct knowledge-sharing sessions and technical training.
- Promote a collaborative and quality-focused team environment.

Required Skills &

- Qualifications:

1. Education:

- Bachelor's or Master's degree in Statistics, Mathematics, Computer Science, Life Sciences, Biostatistics, Pharmacy, or a related field.

2. Experience:

- 610 years of experience in Statistical Programming within the pharmaceutical, biotechnology, or CRO industry.
- Extensive experience supporting Phase IIV clinical trials.
- Experience with regulatory submissions (FDA, EMA, PMDA) is highly preferred.

3.

Technical

Skills:

- Strong expertise in Base SAS and SAS Macro programming.
- Hands-on experience with SAS/STAT procedures.

📌 Senior Statistical Programmer - Clinical SAS (India)
🏢 Softpath Technologies
📍 India