Statistical Programmer

Kelly Science, Engineering, Technology & Telecom; Poland; On-site; PLN 140,000 - 210,000; Full time

Job summary

Kelly is seeking a Statistical Programmer to support clinical trial data analysis and regulatory submissions in pharma. You will program, validate, and document datasets and outputs to ensure accuracy and compliance with industry standards.

In this evergreen pipeline role, you will develop SAS and/or R programs, create SDTM/ADaM datasets, and generate TFLs for study reports while collaborating with statisticians, data managers, and clinical teams. Strong regulatory knowledge is essential.

Qualifications

• Bachelor’s or Master’s degree in Statistics, Mathematics, CS or Life Sciences.
• Proficiency in SAS programming (Base, Macro, SQL).
• Solid understanding of clinical trial data structure and regulatory requirements.
• Experience with SDTM and ADaM datasets.
• Familiarity with CDISC standards.
• Strong written and verbal communication.

Responsibilities

• Develop, test, and validate SAS and/or R programs for clinical data processing and analysis.
• Create, maintain, and document datasets (SDTM, ADaM) per regulatory and company requirements.
• Generate tables, figures, and listings (TFLs) for clinical study reports.
• Collaborate with statisticians, data managers, and clinical teams to ensure data quality and integrity.
• Participate in the review of statistical analysis plans, CRF, and other study-related documents.
• Maintain strict adherence to GCP, FDA, EMA, and ICH guidelines.
• Contribute to data submission packages and regulatory interactions.
• Manage timelines and workload to ensure project milestones are met.

Skills

SAS programming

Base SAS

Macro SAS

SQL

CDISC standards

Clinical data

Education

Bachelor’s or Master’s in Statistics/Math/CS/Life Sciences

Tools

R

Python

Job description

Kelly is pipelining talent for an evergreen Statistical Programmer role in pharma.

This is a pipeline opportunity for proactive candidates interested in joining a global leader in the life sciences industry.

Job Description

As a Statistical Programmer in our Pharmaceutical Company, you will play a crucial role in supporting clinical trial data analysis and regulatory submissions. You will be responsible for programming, validating, and documenting datasets and statistical outputs to ensure accuracy and compliance with industry standards.

Key Responsibilities

• Develop, test, and validate SAS and/or R programs for clinical data processing and analysis.
• Create, maintain, and document datasets (SDTM, ADaM) per regulatory and company requirements.
• Generate tables, figures, and listings (TFLs) for clinical study reports.
• Collaborate with statisticians, data managers, and clinical teams to ensure data quality and integrity.
• Participate in the review of statistical analysis plans, CRF, and other study-related documents.
• Maintain strict adherence to GCP, FDA, EMA, and ICH guidelines.
• Contribute to data submission packages and regulatory interactions.
• Manage timelines and workload to ensure project milestones are met.

Must Haves

• Bachelor’s or Master’s degree in Statistics, Mathematics, Computer Science, Life Sciences, or related field.
• Proficiency in SAS programming (Base, Macro, and SQL).
• Solid understanding of clinical trial data structure and regulatory requirements.
• Experience with SDTM and ADaM dataset creation.
• Familiarity with CDISC standards.
• Strong written and verbal communication skills.
• Attention to detail and ability to work independently or as part of a team.

Nice to Haves

• Experience in R programming or Python.
• Prior experience with submissions to FDA/EMA.
• Exposure to oncology, rare diseases, or other specialized therapeutic areas.
• Knowledge of statistical methods for clinical trials and ability to review statistical outputs.
• Familiarity with other data visualization tools (e.g., Spotfire, Tableau).
• Experience in automation and process optimization.
• Previous experience in a CRO or pharma environment.