Job Information
NEXPRO TECHNOLOGIES INC Statistical Programmer in King Of Prussia, Pennsylvania
Assist the Director of Biostatistics and Data Management in preparing study protocols and reports which may include calculating sample size calculations and generating randomization schedules.
Provide technical & project management skills in SAS programs to analyze and report clinical trial data in Tables, Listings, and Figures & for electronic submissions of SDTM, ADaM datasets in CDISC format.
Use Statistical Analysis Software (SAS) to conduct statistical analysis on clinical trial data to produce tables, reports & graphs.
Maintain other project administration files including protocols, annotated case report forms (CRFs), statistical analysis plan and project related memorandums.
Participate on standard operating procedures, process improvements, system validation, & integration of new tools and technologies.
Work on all SAS language & procedures used in clinical trial reporting including Macro language, BASE SAS, SAS/STAT & SAS/GRAPH in different environments like SAS Enterprise Guide, SAS Studio in different operating systems such as Windows and Unix.
Lead appropriate approaches to database design using expertise in Clinical Data Interchange Standards Consortium (CDISC) standards & CDISC/eCTD requirements for regulatory submissions.
Oversee data integration used for clinical summaries and/or creation and quality control of statistical submission components to regulatory agencies such as FDA, EMA, and NIH.
Use Statistical Analysis Software (SAS) to conduct statistical analysis on clinical trial data to produce tables, reports & graphs.
Review key planning documents (e.g., statistical analysis plan, data presentation plan, data review plan) to ensure alignment with development team objectives and clarity and completeness of programming assumptions and requirements.
Position Requirements: Master's degree or a foreign equivalent degree in Healthcare Informatics, Health Admin, Pharmacology, Toxicology, Pharmacy, Chemistry, Computer Science, Public Health, Bio Informatics, Bio Technology, Statistics or related field.
Special Skills: Position requires travel/relocation to various unanticipated client locations throughout the U.S. with expenses paid by the employer.
Benefits: Medical, Life Insurance and 401K.
Standard Company Benefits.