Senior Biostat Programmer

3 weeks ago

Woodcliff Lake, New Jersey, United States PSG Global Solutions Careers Full time
Job Title: Senior Biostat Programmer

About the Role:
We are seeking a highly skilled Senior Biostat Programmer to join our team at PSG Global Solutions Careers. As a Senior Biostat Programmer, you will be responsible for providing statistical programming and validation support for clinical study reports, overseeing programming activities by external vendors, and coordinating programming activities among study programmers to achieve timely progress in the following areas:

Analysis datasets, statistical tables, figures, listings, Integrated Summaries of Safety (ISS), Integrated Summaries of Efficacy (ISE), DSUR, PSUR, IB, progress reports, electronic submissions, and other internal and external requests.

Accessing and converting data to SAS from Database management system and PC file formats (e.g., MS Excel, text files).

Working with external vendors to develop or monitor the content and structure of SAS data sets.

About Our Client:
Our client is an award-winning clinical development company with 20+ years of experience in clinical research and strategic resourcing. They improve lives globally with proven strategies, comprehensive solutions, and customized delivery models. Serving pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations, they provide strong relationships, connections, and access to great opportunities. Industry expertise sets you up for success with helpful insights, career coaching, and professional training.

Requirements:
Minimum of Bachelors degree in Statistics, Computer Science, Mathematics, or a related science discipline (Masters preferred).
Minimum 8 years experience in SAS programming in biostatistics department environment for phase I-IV clinical trials in a pharmaceutical/CRO environment.
Lead Programmer experience is expected.
Strong managerial/technical understanding of programming and clinical-related issues along with an ability to demonstrate significant leadership of SAS programming technical activities in a clinical pharmaceutical/CRO environment.
Understanding of submission-related activities and experience with agency-related requirements expected. Define.
XML knowledge and familiarity with a submission process is preferred.
Oncology and in-depth ADaM programming required.
Submission support with compliance is expected.
Experience using SAS-Base, MACRO, STAT, GRAPH, ACCESS, MS Office.

What We Offer:
Knowledge of SDTM and ADaM standards.
Proven experience with UNIX and Windows operating systems.
Understanding of the software development life cycle.
Understanding of FDA guidelines.
Good organization, time management, and attention to detail skills needed to work in a stressful environment under tight deadlines while maintaining focus on details and quality.
Applies good judgment and demonstrates initiative to resolve issues.
Proactive and effective working.
Accountable.
Leadership expected.
Strong verbal, written, and interpersonal communication skills needed to work effectively in a team environment, managing that team as required.

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