Principal Statistical Programmer

Organisation Description
EMD Serono, Inc. is a leader in US biotechnology, focusing on reproductive health, metabolic endocrinology, and neurology. More than 500 people work in the world-class facilities in Rockland, MA, and approximately 250 work in the field.
Description

INDEPENDENTLY, PROGRAM (OR WRITE VALIDATION PROGRAMS FOR) AND DOCUMENT TABLES/LISTINGS/GRAPHS FOR CLINICAL TRIALS OR PORTIONS OF CLINICAL TRIALS REQUIRING ROUTINE DATA MANIPULATION AND ANALYSIS. WITH LIMITED DIRECTION, PROGRAM (OR WRITE VALIDATION PROGRAMS FOR) AND DOCUMENT TABLES/LISTINGS/GRAPHS FOR CLINICAL TRIALS REQUIRING COMPLEX DATA MANIPULATION AND ANALYSIS. PROVIDE INPUT INTO GENERAL STANDARDIZATION EFFORTS AND CREATE (OR VALIDATE) GLOBAL MACROS THAT STREAMLINE REPETITIVE OPERATIONS. MENTOR BIOSTATISTICIANS AND STATISTICAL PROGRAMMER/ANALYSTS WITH ADVANCE SAS PROGRAMMING TECHNIQUES.INTERFACE WITH SAS TECHNICAL SUPPORT TO RESOLVE SOFTWARE PROBLEMS.COORDINATE, VALIDATE AND IMPLEMENT SAS UPGRADES AND LICENSES.INDEPENDENTLY PROVIDE INPUT INTO CRF SPECIFICATIONS TO COLLECT DATA SPECIFIED IN THE PROTOCOL AND QUERY CHECK SPECIFICATIONS AND PROVIDE INPUT INTO ANALYSIS PLAN SPECIFICATIONS AND DATA PRESENTATIONS FOR CLINICAL TRIALS REQUIRING COMPLEX DATA MANIPULATION AND ANALYSIS. INDEPENDENTLY PROGRAM (OR WRITE VALIDATION PROGRAMS FOR) PATIENT RANDOMIZATIONS.INDEPENDENTLY CREATE (OR VALIDATE) NONSTANDARD COMPLEX DERIVED DATASETS.CREATE PROJECT AND STUDY PHASE SUB-DIRECTORIES ENSURING THAT ALL PROJECT WORK RESIDES IN THE CORRET PROJECT AND STUDY PHASE SUB-DIRCTORIES.VALIDATE STUDY PHASE FLAGS IN ORACLE TABLES AND DOWNLOAD STUDY PHASE RECORDS FROM ORACLE TABLES TO CREATE ANALYSIS DATASETS. AUDIT CHANGES TO THE DATABASE BETWEEN STUDY PHASES.UNDERSTAND AND FOLLOW ALL STATISTICAL AND STATISTICAL PROGRAMMING SOPS AS WELL AS ANY OTHER RELEVANT SOP.LEAD PROCESS IMPROVEMENT TEAMS AS REQUIRED.EFFECTIVELY COMMUNICATE ANALYSIS SPECIFICATION AND PROGRAMMING/DATA ISSUES THAT ARISE PRIOR TO OR DURING ANALYSIS IN A TIMELY MANNER.
EDUCATION/PROFESSIONAL EXPERIENCEMS, BS (OR EQUIVALENT).8 YEARS PHARMACEUTICAL/BIOTECH OR OTHER RELEVANT EXPERIENCE.FUNDAMENTAL KNOWLEDGE OF RELEVANT STATISTICAL AREAS.FUNDAMENTAL KNOWLEDGE OF RELEVANT CLINICAL AREAS. LANGUAGESENGLISH SKILLS && COMPETENCIESEXPERTISE SAS/BASE, SAS/STAT; KNOWLEDGE OF SAS/CONNECT, SAS/MACRO, SQL.EXCELLENT COMMUNICATION SKILLS.EXTENSIVE KNOWLEDGE OF ICH STATISTICAL AND CLINICAL REPORT GUIDELINES.UNDERSTAND THE REGULATORY REPORTING AND SUBMISSION PROCESS AND ITS ASSOCIATED TIME FRAME.