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.
Similar Jobs
.png)
What We Do
Cerus Corporation is dedicated solely to safeguarding the world’s blood supply and aims to become the preeminent global blood products company. Headquartered in Concord, California, the company develops and supplies vital technologies and pathogen-protected blood components to blood centers, hospitals, and ultimately patients who rely on safe blood. The INTERCEPT Blood System for platelets and plasma is available globally and remains the only pathogen reduction system with both CE mark and FDA approval for these two blood components. The INTERCEPT red blood cell system is under regulatory review in Europe, and in late-stage clinical development in the US. Also in the US, the INTERCEPT Blood System for Cryoprecipitation is approved for production of INTERCEPT Fibrinogen Complex, a therapeutic product for the treatment and control of bleeding, including massive hemorrhage, associated with fibrinogen deficiency. For more information about Cerus, visit www.cerus.com and follow us on LinkedIn.
