Contract Statistical Programmer

About Cerus:

Cerus aims to be the global leader and trusted partner of blood centers and hospitals whose technology, services, and commitment are the lifeblood of safe and accessible blood for patients around the world.

This is a 6 month remote opportunity based out of the US.

Primary Responsibilities:

Provide SAS programming support for analyzing clinical trials, supporting registrations, and creating of reports for publications and other ad hoc analyses

Develop SAS programs to generate TLFs to meet requirements using Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/SQL within applicable timelines

Draft and/or review data specifications and build analysis datasets

Review CRF design, data management plan, data validation plan, and edit check specifications

Interact with statisticians and interdisciplinary teams on timelines and content of deliverables

Follow required validation and verification requirements for software developed within the department, including verifying software developed by other staff members through peer reviews.

Develop, validate and maintain macros and tools for general use within the Biostatistics department to enhance the efficiency and quality of output produced

Prepare datasets and supporting documentation that meet the CDISC SDTM and ADaM standards for use in submissions as required

Provide technical leadership and support to members of the Biostatistics department as required

Apply and promote good programming practices

Qualifications/Requirements/Skills:

B.S., M.S., or Ph.D. degree in statistics, biostatistics, computer science or closely related field with a minimum of 7 years pharmaceutical/medical device/CRO related experience as a SAS programmer analyzing clinical trial data

Excellent working knowledge of Base SAS (including macro language, Proc SQL, and ODS), SAS/GRAPH, and SAS/STAT

Good working knowledge of CDISC SDTM and ADaM models

Experience in integrating ISS/ISE data preferred

Experience using other statistical packages (e.g., S-plus, R) a plus

Knowledge of and ability to adhere to GCP principles and relevant regulatory requirements

An aptitude for quantitative problem-solving with the capacity to troubleshoot and work independently

Ability to follow guidelines and specifications on validation procedures and data transfer procedures

Strong communication skills with the ability to interface at all levels; comfortable communicating workload to assist in managing priorities

Flexible; ability to adapt to changing priorities and work independently with minimal supervision

Experience running SAS in a Windows environment

Able to set realistic timelines for assigned tasks and follow through to completion.

All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.