Principal Statistical Programmer

Emmess Services; Bengaluru; In loco; INR 900.000 - 1.600.000; Tempo pieno

Descrizione del lavoro

Emmess Services seeks a Principal Statistical Programmer to design, develop, validate, and maintain statistical programming deliverables for clinical trials and regulatory submissions. This senior role provides technical leadership on studies, applying CDISC standards and regulatory guidance.

You will lead SDTM/ADaM development, program TLFs, review SAPs, and mentor junior programmers while collaborating with Biostatistics, Data Management, and Clinical teams to ensure timely and accurate

Competenze

• Expert in SAS Base, Macro and SQL with solid SDTM/ADaM experience.
• Proven track record delivering regulatory submissions.
• Strong understanding of ICH GCP and FDA/EMA expectations.

Mansioni

• Lead development, validation, and maintenance of SDTM and ADaM datasets and documentation.
• Program complex Tables, Listings, and Figures (TLFs) for study reports and submissions.
• Review SAPs and ensure correct implementation in code.
• Serve as lead programmer on multiple studies, coordinating teams and CROs.
• Provide mentorship to junior programmers and contractors.
• Collaborate with Biostatistics, Data Management, and Clinical teams to deliver outputs.
• Ensure compliance with industry standards and internal SOPs.
• Contribute to programming standards and reusable code libraries.
• Participate in QC, peer review, and validation of deliverables.
• Prepare and review submission-ready datasets and define.xml for regulators.
• Support ISS and ISE analyses for NDA/BLA/MAA submissions.

Conoscenze

SAS Base

SAS Macro

SAS SQL

CDISC SDTM

CDISC ADaM

Regulatory submissions

ICH GCP

Quality documentation

Formazione

Bachelor's or Master’s in Computer Science/Statistics/Life Sciences

Descrizione del lavoro

Job Summary

The Principal Statistical Programmer is a senior-level contributor responsible for designing, developing, validating, and maintaining statistical programming deliverables to support clinical trials and regulatory submissions. This individual serves as a technical expert on study and project teams, providing leadership in the application of statistical programming standards and regulatory guidance (e.g., CDISC, ICH, FDA).

Responsibilities

• Lead the development, validation, and maintenance of SDTM and ADaM datasets and associated documentation.
• Program complex Tables, Listings, and Figures (TLFs) for study reports, publications, and submissions.
• Review and interpret statistical analysis plans (SAPs) to ensure accurate implementation in code.
• Serve as lead programmer on multiple studies and/or projects, coordinating efforts across internal teams and CROs.
• Provide technical oversight and mentoring to junior programmers and contractors.
• Collaborate closely with Biostatistics, Data Management, and Clinical teams to deliver timely and accurate outputs.
• Ensure programming deliverables comply with industry standards (CDISC, FDA, EMA) and internal SOPs.
• Contribute to the development and implementation of programming standards and reusable code libraries.
• Participate in quality control, peer review, and validation of programming deliverables.
• Prepare and review submission ready datasets, define.xml files, and reviewer guides for regulatory authorities (e.g., FDA, EMA).
• Support integrated summaries of safety (ISS) and efficacy (ISE) analyses for NDA/BLA/MAA submissions.
• Use tools such as Pinnacle 21, OpenCDISC, and define.xml generators to ensure submission compliance.
• Performs other duties as assigned.
• Complies with all policies and standards.

Qualifications

• Bachelors Degree or Masters degree in Computer Science, Statistics, Mathematics, Life Sciences, or related field.
• 7-9 years in statistical programming within the pharmaceutical, biotech, or CRO industry.
• Expert level proficiency in SAS Base, SAS Macro, and SAS SQL.
• In depth experience with CDISC SDTM and ADaM standards.
• Proven track record of supporting clinical trial reporting and regulatory submissions.
• Strong understanding of ICH GCP, 21 CFR Part 11, and FDA and EMA regulatory expectations.
• Excellent problem solving skills and attention to detail.
• Strong communication and collaboration skills.

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.