Statistical Programmer – Clinical SAS

Teamware Solutions; Bengaluru; On-site; INR 1,500,000 - 2,300,000; Full time

Job summary

Teamware Solutions in Bengaluru, India, seeks experienced Statistical Programming professionals to support clinical development, analysis, and regulatory submissions.

Roles include Statistical Programming Consultant (4–6 years) and Senior Statistical Programmer (6–8 years). You will work with SAS, CDISC standards (SDTM/ADaM), eDC, and deliver ADaM datasets and e-submission packages.

Collaborate with vendors, review SAPs, and ensure regulatory compliance and data quality.

Qualifications

• Bachelor's degree in Statistics, Biostatistics, Mathematics, CS, Life Sciences or related field.
• Strong hands-on SAS/Clinical Statistical Programming experience.
• Solid knowledge of CDISC standards, SDTM, ADaM, and clinical data structures.
• Experience with clinical data processing including eDC, SDTM, and upstream data sources.
• Ability to generate ADaM datasets, Data Definition Tables, and e-submission packages.
• Support regulatory submissions and related deliverables; interpret SAPs.
• Collaborate with vendors on programming standards and data transfers; ensure regulatory compliance.
• Familiarity with Pinnacle 21, XML, relational databases, and MS Office.

Responsibilities

• Support clinical development, analysis, and regulatory submissions.
• Develop SDTM/ADaM datasets and downstream deliverables.
• Validate programs and ensure data quality and traceability.
• Review SAPs and interpret planning documents; liaise with vendors.

Skills

SAS

Clinical SP

CDISC SDTM

ADaM

eDC

Pinnacle 21

XML

Relational DBs

MS Office

Regulatory submissions

SAPs

R

Linux/Unix

Education

Bachelor’s degree in Statistics/Biostatistics/Mathematics/CS/Life Sciences

Tools

R

Linux/Unix

Job description

We are looking for experienced Statistical Programming professionals to join our team and support clinical development, analysis, and regulatory submission activities.

Positions:

Statistical Programming Consultant / Senior Statistical Programmer

• Consultant: 4–6 years
• Senior: 6–8 years

Education:

Bachelor’s degree in Statistics, Biostatistics, Mathematics, Computer Science, Life Sciences, or related field

• Strong hands‑on experience in SAS / Clinical Statistical Programming
• Perform programming validation and ensure quality of datasets and outputs
• Strong understanding of CDISC standards, SDTM, ADaM, and clinical data structures
• Experience with clinical data processing, including eDC, SDTM, and upstream data sources
• Generate downstream deliverables including ADaM, Data Definition Tables, and e-submission packages
• Support regulatory submissions and review submission‑related deliverables
• Review and interpret Statistical Analysis Plans (SAPs) and other clinical planning documents
• Work with vendors on programming standards, specifications, conventions, and data transfers
• Ensure compliance with regulatory requirements, SOPs, and industry standards
• Experience with Pinnacle 21, XML, relational databases, and MS Office
• Strong understanding of clinical trials, statistical terminology, medical terminology, and protocol design

Good to Have:

• Experience supporting NDA, BLA, MAA, or other regulatory filings
• Knowledge of the drug development process and global regulatory requirements
• Experience with R
• Exposure to Linux/Unix environments