Statistical Programmer

Responsibilities:

Lead the development, validation, and maintenance of statistical programs using SAS to generate tables, listings, and figures (TLFs) for clinical trial data analysis.

Develop and maintain SDTM domains in accordance with CDISC guidance.

Create and optimize ADaM datasets, Tables, Figures, Listings (TFLs) and Analysis content.

Support the creation of statistical outputs for clinical study reports (CSRs), regulatory submissions, and publications.

Prepare documentation for regulatory submissions, including electronic submissions to the FDA and other global health authorities

Perform data cleaning, validation, and preparation tasks to ensure high-quality datasets for analysis.

Prepare and maintain thorough documentation of programming activities, including specifications, programming code, and validation reports.

Participate in the development of and ensure compliance to Standard Operating Procedures (SOPs), policies, and guidelines.

Establish and implement statistical programming standards and comply with industry standards and regulatory requirements among project team members and across all studies.

Requireme nts:

Minimum of a bachelor's degree required; MS degree is preferred. (statistics, biostatistics, or closely related field)

5 years' experience with SAS and clinical programming within the biotech / pharmaceutical industry.

Proficiency in SAS programming, including experience with SAS macro language, data step programming, and PROC SQL.

Strong knowledge of CDISC and CDASH standards, including SDTM and ADaM datasets, and experience with regulatory submission requirements.

Experience with clinical trial data and understanding of the drug development process.

Proficiency in industry standards, medical terminology, and clinical trial methodologies.

Excellent problem-solving skills and attention to detail, with the ability to work independently and manage multiple projects simultaneously

Strong communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.