Senior Programmer

Overview

Our client SCiAN Services is looking for a Principal Statistical Programmer to provide high quality programming solutions to support clinical studies across various therapeutic areas. The person will work closely with a team of SAS programmers and Biostatisticians to support and perform analysis of clinical data.

Responsibilities

Act as the Lead Programmer

Responsible for SDTM package : author / review / update SDTM specifications, program / review SDTM datasets, validate SDTM datasets

Author SDTM reviewer’s guide and assess impact of protocol amendments to SDTM deliverables

Collaborate with Senior / Principal Biostatistician to update ADaM specifications and review / QC ADaM and TLFs programmed by junior staff

Program tables, listings and figures as per SAP for clinical research studies

Import data from 3rd party clients (e.g., central lab transfers) and prepare data exports for clients

Perform data checks (quality control) to ensure data integrity and accuracy

Develop, test, document, and maintain a library of SAS statistical macros

Support CDM group in validation of clinical data

Undertake project management activities as needed, including managing project team of statistical programmers and ensuring timely, high-quality deliverables

Qualifications

B.A. / B.S. in Statistics, Mathematics or Computer Science

Minimum of 4 years of clinical programming experience using SAS

Lead experience overseeing other programmers and projects

Hands-on experience with CDISC, SDTM and ADaM standards

CRO experience preferred

Knowledge of Pinnacle 21

Strong organizational skills and high accuracy with timelines

Strong verbal and written communication skills

Strong leadership and ability to multitask in a fast-paced environment

Demonstrated experience in statistical programming (SAS preferred) in the Pharma / Biotech industry

Knowledge of FDA / ICH regulations and guidelines

Cooperative, team-oriented, self-motivated and detail-oriented

Education levels

B.Sc. or MSc. in Statistics (preferred) or related field

Seniority level

Mid-Senior level

Employment type

Full-time

About SCiAN

SCiAN has 34 years in the Biotechnology / Pharmaceutical Industry, offering services in Pharmacovigilance, Biostatistics, Data-Management, and other custom-database solutions.

Equal Opportunity

We are an equal opportunity employer and support diversity in our workplace.

Experience

SCiAN has been part of the Biotechnology / Pharmaceutical Industry for 34 years. We offer services in Pharmacovigilance, Biostatistics, Data-Management, as well as other custom-database solutions.

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