Job Title: Statistical Programmer
Experience: 4+ Years
Domain: Clinical Research / Life Sciences
Job Summary:
We are seeking an experienced Statistical Programmer with 4+ years of expertise in clinical data analysis and reporting. The ideal candidate should have strong programming skills in R, hands-on experience with PK/PD analysis, and a solid understanding of clinical trial phases (I–IV). The role involves developing and validating statistical outputs including TLFs (Tables, Listings, and Figures) in compliance with regulatory standards.
Key Responsibilities
- Perform data review, validation, and cleaning activities for clinical trial data
- Generate and resolve data queries to ensure data accuracy and completeness
- Review Case Report Forms (CRFs) and ensure compliance with study protocols
- Conduct data discrepancy management and follow up with sites for query resolution
- Support database lock activities and ensure readiness for analysis
- Assist in edit check programming and validation
- Ensure adherence to CDISC standards, GCP, and regulatory guidelines
- Perform data reconciliation (e.g., SAE, lab data, external vendor data)
- Prepare data management reports and metrics
- Collaborate with stakeholders to ensure timely delivery of clinical data
Key Responsibilities:
- Develop, validate, and maintain statistical programs using R programming for clinical trial data analysis
- Generate Tables, Listings, and Figures (TLFs) as per Statistical Analysis Plan (SAP)
- Perform PK/PD (Pharmacokinetics/Pharmacodynamics) data analysis and reporting
- Support clinical studies across Phases I–IV
- Collaborate with biostatisticians to interpret analysis requirements and translate them into programming solutions
- Ensure compliance with CDISC standards (SDTM, ADaM) where applicable
- Conduct quality control (QC) and validation of datasets and outputs
- Prepare documentation including programming specifications, validation plans, and reports
- Support regulatory submissions (e.g., FDA, EMA)
Required Skills & Qualifications:
- 4+ years of experience in statistical programming within clinical research
- Strong proficiency in R Programming (mandatory)
- Hands-on experience with TLFs generation and validation
- Good understanding of PK/PD analysis concepts
- Experience working on clinical trial data across Phases I–IV
- Familiarity with CDISC standards (SDTM/ADaM)
- Knowledge of regulatory guidelines and submission requirements
- Strong analytical and problem-solving skills
- Good communication and stakeholder coordination abilities
Preferred Qualifications:
- Experience across multiple therapeutic areas such as:
- Oncology
- Cardiovascular
- CNS (Central Nervous System)
- Infectious Diseases
- Exposure to tools like SAS (added advantage)
- Experience in submission-ready datasets and define.xml
Soft Skills:
- Attention to detail and high-quality delivery focus
- Ability to work independently and in cross-functional teams
- Time management and adherence to project timelines.
Skills: cdisc standards,pk/pd,r,validation
