Clinical SAS Programmer

Katalyst CRO

Boston (MA)

On-site

USD 58,677 - 93,902

Full time

14 days+

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Job summary

A biotech company is looking for a Clinical SAS Programmer to design and code SAS programs for clinical projects. You'll produce regulatory compliant datasets and validate tables in a timely manner. The ideal candidate will have 3+ years of experience in SAS programming and knowledge of CDISC standards. This role offers competitive pay and an opportunity to work in a dynamic environment based in Boston, MA.

Qualifications

3+ years of experience in SAS programming for clinical trials.
Knowledge of CDISC standards for SDTM and ADaM.
Experience with FDA and ICH regulations.

Responsibilities

Design and code SAS programs for clinical projects.
Produce CDISC compliant datasets.
Validate tables and figures in a timely manner.
Perform quality control checks on SAS code.

Skills

SAS programming

Statistical reporting

Problem-solving

Communication skills

Organizational skills

Education

MS in Statistics, Computer Science, or a related field

BS in Statistics, Computer Science, or a related field

Job description

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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 quality checks for clinical study raw data and report the findings to Data Management
Reviews or author eCRF, SDTM and ADaM datasets specifications for datasets programming
Provides programming support for adhoc analysis.
Identifies problems and develops global tools that increase the efficiency and capacity of the Statistical Programming group (e.g., macros or graphical user interface applications)

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.

Seniority level