We're looking for a Senior Biostatistical Programmer, working in the Pharmaceuticals & Medical Products industry in Woodcliff Lake, New Jersey, United States.
Provides statistical programming and validation support for clinical study reports, overseeing programming activities by external vendors (e.g., CROs) when necessary and coordinating programming activities among the study programmers to achieve timely progress in the following areas: SDTM datasets, ADaM datasets, statistical tables, figures, listings,and other internal and external requests (e.g., publications).
Works with external vendors in order to develop or monitor the content and structure of SAS data sets.
Works closely with clinicians, statistician, and publication managers to generate and QC outputs for publications; reviews publication (abstract/ manuscripts) to ensure accuracy, quality and soundness of statistical methodologies; coordinates internal resource utilization for publication and generate activities metrics for management review.
Provides input to the database and CRF development, creating edit check programs and providing feedback to the data management.
Provides input in developing statistical analysis plans, specifications of analysis datasets, validation plans, and other related documents.
The pay range we are offering is 87 to 92 per hour. This position may present an opportunity to go permanent.
Our client is an award-winning clinical development company. Improving lives globally with 20+ years experience in clinical research and strategic resourcing. Elevating results with proven strategies, comprehensive solutions, and customized delivery models.
Serving pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations.
Strong relationships provide you connections and access to great opportunities. Industry expertise sets you up for success with helpful insights, career coaching, and professional training. Grow and learn while you put your skills to work.
Experience Required for Your Success
Bachelors degree in Statistics, Computer Science, Mathematics, or a related science discipline (Masters degree preferred)
10+ years of experience in SAS programming for phase I-IV clinical trials in a pharmaceutical/CRO environment
FDA submission experience preferred
Some project experience in a pharmaceutical/CRO programming environment or demonstrated leadership in a clinical pharmaceutical/CRO environment
Experience using SAS-Base, MACRO, STAT, GRAPH, ACCESS, MS Office
Experience in CDISC data standards, e.g. SDTM and ADaM
Proven experience with Unix and Windows operating systems
Understanding of the software development life cycle
Understanding of FDA guidelines
What Do You Think?
Does your experience reflect what it takes to be successful in this role? Do the work and challenges get you excited about what's possible? Apply here.