Contract-2-Hire (C2H) Job- Sr. Statistical Programmer

******Contract-2-Hire (C2H) Job********

Job Title: Sr. Statistical Programmer

Experience Required: 710 Years

Location: Mumbai / Bangalore / Hyderabad / Pune

Work Mode: 5 Days Work from Office

Hire Type: Contract-2-Hire (C2H)

Job Summary:

We are looking for an experienced Sr. Statistical Programmer with strong expertise in clinical data programming, statistical analysis, and reporting. The ideal candidate will be responsible for developing, validating, and maintaining statistical programs to support clinical trial data analysis, regulatory submissions, and reporting activities. The role requires strong hands-on experience with SAS programming, CDISC standards, and clinical trial programming processes.

Key Responsibilities:

Develop, validate, and maintain statistical programs for clinical trial data analysis and reporting.

Perform SAS programming activities including SDTM, ADaM datasets, TLFs (Tables, Listings, and Figures), and statistical outputs.

Create and validate datasets according to CDISC standards (SDTM/ADaM).

Develop complex SAS programs/macros for data manipulation, analysis, and reporting.

Perform programming for clinical study reports (CSR), regulatory submissions, and interim/final analysis.

Ensure compliance with SOPs, programming standards, and regulatory guidelines.

Review statistical programming specifications and translate requirements into programming solutions.

Perform quality control (QC) checks and validation of datasets and outputs.

Collaborate with statisticians, clinical data managers, and cross-functional teams.

Support regulatory submissions (FDA/EMA/PMDA) by preparing submission-ready datasets and outputs.

Troubleshoot programming issues and provide technical solutions.

Mentor junior statistical programmers and support best practices.

Required Technical Skills

7–10 years of experience in Statistical Programming / Clinical SAS Programming.

Strong hands-on experience with SAS Base Programming.

Expertise in:

SAS Macros

PROC SQL

Data Step Programming

Statistical procedures

Data validation and QC programming

Strong experience working with:

SDTM

ADaM

CDISC Standards

TLF Programming

Experience in clinical trial phases (Phase I–IV).

Good understanding of clinical trial processes and regulatory requirements.

Experience working with large clinical datasets and complex programming requirements.

Knowledge of submission standards and regulatory datasets.