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Statistical Programmer
2 months ago
Katalyst Healthcares & Life Sciences is seeking a highly skilled Statistical Programmer to join our team.
Responsibilities:- Lead the Development of Statistical Programs: Develop, validate, and maintain statistical programs using SAS to generate tables, listings, and figures (TLFs) for clinical trial data analysis.
- SDTM Domain Development: Develop and maintain SDTM domains in accordance with CDISC guidance.
- ADaM Dataset Creation: Create and optimize ADaM datasets, Tables, Figures, Listings (TFLs) and Analysis content.
- Statistical Outputs: Support the creation of statistical outputs for clinical study reports (CSRs), regulatory submissions, and publications.
- Documentation Preparation: Prepare documentation for regulatory submissions, including electronic submissions to the FDA and other global health authorities.
- Data Cleaning and Validation: Perform data cleaning, validation, and preparation tasks to ensure high-quality datasets for analysis.
- Programming Documentation: Prepare and maintain thorough documentation of programming activities, including specifications, programming code, and validation reports.
- Standard Operating Procedures: Participate in the development of and ensure compliance to Standard Operating Procedures (SOPs), policies, and guidelines.
- Statistical Programming Standards: Establish and implement statistical programming standards and comply with industry standards and regulatory requirements among project team members and across all studies.
- Education: Minimum of a bachelor's degree required; MS degree is preferred in statistics, biostatistics, or a closely related field.
- Experience: 5 years' experience with SAS and clinical programming within the biotech/pharmaceutical industry.
- Skills: 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.
- Additional 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.
