Senior Statistical Programmer

Emmes Corporation; Bengaluru; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Emmes Corporation is seeking an experienced Statistical Programmer to provide advanced SAS programming for complex clinical research projects in Bengaluru. You will develop, validate, and maintain datasets and statistical outputs, focusing on SDTM/ADaM in line with CDISC standards.

Ideal candidates have 10+ years of experience, strong SAS expertise, and a track record in regulatory-compliant deliverables. Collaboration with statisticians and cross-functional teams is essential.

Qualifications

• 10+ years of statistical programming experience in clinical research.
• Strong proficiency in SAS including Base SAS, Macros, and PROC SQL.
• Experience with SDTM/ADaM datasets and CDISC standards.

Responsibilities

• Provide advanced statistical programming for complex clinical projects.
• Develop and maintain SAS programs for datasets and outputs.
• Create and validate TLFs/TLGs per SAPs and study specs.
• Translate protocols and programming specs into deliverables.
• Ensure regulatory compliance (GCP, FDA, EMA, ICH).
• Support QC, validation, and data review processes.
• Collaborate with statisticians and cross-functional teams.
• Contribute to standardization and process improvements.

Skills

SAS programming

R/Python (advantage)

Regulatory knowledge

Communication & collaboration

Data analysis problem solving

Tools

SAS

Base SAS

SAS Macros

PROC SQL

SDTM

ADaM

CDISC standards

Pinnacle 21/OpenCDISC

Job description

Role & responsibilities

• Provide advanced statistical programming support for complex clinical research projects.
• Develop, validate, and maintain clinical trial datasets and statistical outputs using SAS.
• Apply advanced Base SAS, SAS Macros, and PROC SQL programming techniques.
• Develop and support SDTM and ADaM datasets in accordance with CDISC standards.
• Program and validate Tables, Listings, and Figures (TLFs/TLGs) based on study specifications and statistical analysis plans.
• Translate protocols, SAPs, programming specifications, and mock shells into accurate programming deliverables.
• Perform data manipulation, derivations, QC, validation, troubleshooting, and review of clinical trial datasets and outputs.
• Prepare programming documentation, specifications, annotations, and related technical documentation.
• Ensure programming deliverables meet applicable GCP, FDA, EMA, ICH, and other regulatory requirements.
• Develop efficient, well-documented, and reproducible programming code.
• Collaborate with statisticians, biostatisticians, clinical data management, and other cross-functional teams.
• Manage multiple study deliverables and priorities while maintaining quality and timelines.
• Contribute to standardization and continuous improvement of statistical programming processes.

Preferred candidate profile

• 10+ years of relevant statistical programming experience, with 1012 years preferred.
• Candidates with 13-14 years of experience may also be considered if the technical fit is strong.
• Strong hands-on experience as a Statistical Programmer / Senior Statistical Programmer / Principal Statistical Programmer.
• Strong clinical statistical programming experience within a pharmaceutical, CRO, biotechnology, or clinical research environment.
• Strong proficiency in SAS, including Base SAS, SAS Macros, and PROC SQL.
• Strong hands-on experience with SDTM, ADaM, TLF/TLG, and CDISC standards.
• Good understanding of clinical trial data flow and programming requirements.
• Experience working with protocols, SAPs, programming specifications, mock shells, and clinical trial datasets.
• Experience with programming QC, validation, and regulatory-compliant deliverables.
• Knowledge of GCP and FDA/EMA/ICH regulatory requirements.
• R or Python experience is an added advantage but not mandatory.
• Additional exposure to Define.xml, CRF annotation, Pinnacle 21/OpenCDISC, and regulatory submissions is desirable.