Responsibilities
Programming & Validation
Develop, test, and validate SDTM and ADaM datasets according to CDISC standards.
Program Tables, Listings, and Figures (TLFs) in support of clinical study reports (CSRs) and regulatory submissions.
Translate statistical analysis plans (SAPs) into accurate and efficient code.
Project Support
Serve as the lead programmer on individual studies or studies within a program.
Collaborate with cross functional teams including Biostatisticians, Clinical Data Managers, and Regulatory personnel.
Ensure timely and accurate delivery of programming deliverables to support clinical timelines.
Quality & Compliance
Conduct independent quality checks on programming outputs.
Maintain programming documentation according to internal SOPs and regulatory guidelines.
Ensure compliance with GCP, ICH, and 21 CFR Part 11 standards.
Process Improvement
Contribute to the development and refinement of internal programming standards, macros, and reusable code libraries.
Identify opportunities to optimize workflows and improve efficiency within the programming team.
Performs other duties as assigned
Complies with all policies and standards
Qualifications
Bachelor's Degree Computer Science, Statistics, Mathematics, Life Sciences, or a related field. Required or
Master's Degree Computer Science, Statistics, Mathematics, Life Sciences, or a related field. Preferred
4-6 years as a statistical programmer in a pharmaceutical, biotech, or CRO environment. Required
Strong programming skills in SAS as Base, Macro, SQL; familiarity with R or Python is a plus. High
In depth knowledge of CDISC SDTM and ADaM standards. High
Experience supporting clinical trial reporting and preparing data for regulatory submissions as FDA, EMA. High
Excellent attention to detail, problem solving, and communication skills. High
Ability to work independently and collaboratively in a fast paced environment. High
If you’re looking for a career where your work advances global health and where scientific excellence meets real-world impact, join us and be part of something bigger. One Team, One Purpose.
CONNECT WITH US!
Find us on LinkedIn:/the-emmes-group/
Visit our website:https://www.theemmesgroup.com/
Programming & Validation
Develop, test, and validate SDTM and ADaM datasets according to CDISC standards.
Program Tables, Listings, and Figures (TLFs) in support of clinical study reports (CSRs) and regulatory submissions.
Translate statistical analysis plans (SAPs) into accurate and efficient code.
Project Support
Serve as the lead programmer on individual studies or studies within a program.
Collaborate with cross functional teams including Biostatisticians, Clinical Data Managers, and Regulatory personnel.
Ensure timely and accurate delivery of programming deliverables to support clinical timelines.
Quality & Compliance
Conduct independent quality checks on programming outputs.
Maintain programming documentation according to internal SOPs and regulatory guidelines.
Ensure compliance with GCP, ICH, and 21 CFR Part 11 standards.
Process Improvement
Contribute to the development and refinement of internal programming standards, macros, and reusable code libraries.
Identify opportunities to optimize workflows and improve efficiency within the programming team.
Performs other duties as assigned
Complies with all policies and standards
Bachelor's Degree Computer Science, Statistics, Mathematics, Life Sciences, or a related field. Required or
Master's Degree Computer Science, Statistics, Mathematics, Life Sciences, or a related field. Preferred
4-6 years as a statistical programmer in a pharmaceutical, biotech, or CRO environment. Required
Strong programming skills in SAS as Base, Macro, SQL; familiarity with R or Python is a plus. High
In depth knowledge of CDISC SDTM and ADaM standards. High
Experience supporting clinical trial reporting and preparing data for regulatory submissions as FDA, EMA. High
Excellent attention to detail, problem solving, and communication skills. High
Ability to work independently and collaboratively in a fast paced environment. High
If you’re looking for a career where your work advances global health and where scientific excellence meets real-world impact, join us and be part of something bigger. One Team, One Purpose.
CONNECT WITH US!
Find us on LinkedIn:/the-emmes-group/
Visit our website:https://www.theemmesgroup.com/
