Clinical SAS Programmer

Katalyst Healthcares & Life Sciences; Newark (NJ); On-site; USD 60,000 - 80,000; Full time

Job summary

Katalyst Healthcares & Life Sciences is seeking candidates for an entry level position in statistical programming. The role involves designing and coding SAS programs, producing regulatory compliant datasets, and performing quality checks and validations on outputs. Ideal candidates have at least a BS in Statistics or Computer Science with relevant experience.

Strong SAS programming skills and knowledge of CDISC standards are required. The position will work with multidisciplinary teams in drug safety and clinical research.

Qualifications

• MS in related field with 3+ years or BS with 5+ years.
• Experience in statistical programming for clinical trials.
• Excellent SAS programming skills.

Responsibilities

• Designs and codes SAS programs for clinical projects.
• Produces CDISC compliant datasets.
• Validates output produced by other programmers.

Skills

SAS programming

Statistical reporting

Problem-solving

Communication skills

Education

MS in Statistics, Computer Science, or a related field (3 years experience)

BS in Statistics, Computer Science, or a related field (5 years experience)

Tools

BASE/SAS

SAS/STAT

SAS/GRAPH

SAS MACROS

Job description

• Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.
• We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners.

Job Description

Responsibilities:

• Effectively designs and codes SAS programs using BASE/SAS, SAS/STAT, SAS/GRAPH and SAS MACROS for assigned clinical projects(s).
• Produces and delivers CDISC and regulatory compliant SDTM, and ADaM standard datasets.
• Creates and validates tables, figures and listings (TFLs) in a timely and high-quality fashion, consistently meeting objectives of the study, and regulatory requirements.
• Provides input in the design and development of case report forms and clinical databases.
• Performs quality control checks/validation of SAS code and output produced by other Statistical Programmers for SDTM datasets, ADaM datasets and TFLs.
• Programs for quality checks for clinical study raw data and report the findings to Data Management.
• Provides input in the design and development of case report forms and clinical study databases.
• Reviews or author aCRF, SDTM and ADaM datasets specifications for datasets programming.

Requirements:

• MS in Statistics, Computer Science, or a related field with at least 3 years or BS in Statistics, Computer Science, or a related field with at least 5 years.
• Experience in providing statistical programming support to early and late phase clinical trials.
• Excellent skills in SAS programming and statistical reporting.
• Knowledge of CDISC standards for SDTM and ADaM and FDA electronic data submission requirements.
• Familiarity with FDA and ICH regulations and guidelines.
• Excellent problem-solving skills.
• Good written and verbal communication skills and organizational and documentation skills.
• Ability to work on a multidisciplinary team that may include Biostatistics, Medical Directors, Data Management, Medical Writing, Pharmacovigilance, Clinical Operations, Medical Affairs, etc.
• Ability to prioritize and multi-task effectively.
• Demonstrated positive attitude and the ability to work well with others.

Additional Information

All your information will be kept confidential according to EEO guidelines.