Offer summary

Qualifications:

B.S., M.S., or Ph.D. in statistics, biostatistics, computer science, or a related field with at least 7 years of experience as a SAS programmer., Proficient in Base SAS, including macro language, Proc SQL, and ODS, as well as SAS/GRAPH and SAS/STAT., Familiarity with CDISC SDTM and ADaM models, and experience with statistical packages like R is a plus., Strong communication skills and the ability to work independently while managing priorities..

Key responsibilities:

Provide SAS programming support for clinical trial analysis and report generation.

Develop SAS programs to create TLFs and draft/review data specifications.

Interact with interdisciplinary teams and ensure adherence to validation and verification requirements.

Prepare datasets that meet CDISC standards and provide technical leadership within the Biostatistics department.

Job description

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.

Required profile