Princeton Pharmatech is a specialized provider of biostatistics and programming solutions to the pharmaceutical, biotechnology, life science industries and research institutions worldwide. With headquarters in Princeton, New Jersey and San Francisco, CA we have provided biostatistics and programming solutions in various therapeutic areas leading to IND and NDA submissions in the US, Europe and Japan. The Principal SAS Programmer will be responsible for statistical programming for the client’s clinical studies. In this role, you will develop and validate SAS programs for data presentation, analyses, and provide programming support to project team members. Our Ideal candidate will have a strong work ethic capable of thriving in a high growth, fast paced and intellectual environment.
Responsibilities
Serves as lead programmer for assigned projects to provide statistical and programming support in one or more Phase I-III clinical studies
Design and perform quality checks on analysis datasets, tables, listings, figures (TFL), and written reports to support clinical trial results using SAS
Create and review annotated CRF to STDM datasets
Produce and maintain technical programming specification documents
Lead and actively participate in client and project review meetings
Communicate with clients regarding study protocol or statistical analysis issues
Validate statistical deliverables and ensure that appropriate statistical methods are utilized
Ensure adherence to industry standards and regulatory requirements
Facilitate the development and application of adequate statistical methods in clinical research
Requirements
PhD or MS degree in Statistics, Biostatistics or related field
5+ years of relevant work experience in CRO, biotech, pharmaceutical, or life sciences industry
Familiarity with clinical trial design and analysis activities and knowledge of regulatory guidelines (FDA/EMA, ICH/GCP)
Experience with NDA/BLA submission activities
Experience in statistical programs such as Statistical Analysis System (SAS), CDISC and SDTM
Understanding of Ultra Compare software
Maintain awareness of industry standards, regulatory requirements, departmental guidelines, and Standard Operating Procedures (SOP’s)
Excellent organizational skills, time management, ability to prioritize workload, and meet deadlines
Excellent communication and interpersonal skills to effectively interact with others
Job Category: Principal Statistical Programmer
Job Type: Remote
Job Location: New Jersey