High Priority Position :: Senior Statistical Programmer || REMOTE
Babu S
Hope you are doing great today...
Sr Statistical Programmer
Location: Cambridge, MA
COVID-19 Vaccination Required - REMOTE ASSIGNMENT
REPORTING RELATIONSHIP:
Associate Director, Statistical Programming or above
SCOPE:
• Generate or validate SAS data sets, listings, tables and figures, as well as supporting documentation (i.e., define.xml) for clinical studies.
• Enforce the appropriate standards in the department.
• Responsible for planning and tracking the statistical programming activities such as designing, developing, validating, updating, and documenting SAS programs to generate analysis datasets, data listings, summary tables, and statistical graphs supporting safety and efficacy analyses.
KEY RESPONSIBILITIES:
• Lead on clinical studies and integrated analyses and provide guidance and training to other lower-level personnel.
• Develop or evaluate software tools, SAS macros, utilities to automate programming activities and support Biometrics team collaboration
• Contribute and implement to statistical analysis plans; provide additional expertise in the analysis of clinical trial when it relates to protocol development, case report form design and data collection.
• Review Data Management Plan, Data Transfer Plan, Data Validation Plan and Edit Check Specifications and provide comments.
• Work closely with Biostatistics to create analysis specifications following the instructions provided in Statistical Analysis Plan (SAP)
• Create CDISC SDTM and ADaM files, SAS export files, Define.xml and Reviewer's Guide for Electronic Submission.
• Perform Data analysis, statistical analysis, generate safety and efficacy tables, listings and graphs using Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/SQL and SAS/ODS.
• Interact with Statisticians and other clinical team, perform ad hoc analysis and generate outputs according to the requirements.
• Help identify issues and initiates resolution of the problems.
• Act as a liaison between statistical programming, subcommittees and project teams as needed.
• May serve as external spokesperson for the organization.
• Create/acquire tools to improve programming efficiency or quality control.
• Stay current with industry trend, best practices and improves statistical programming methodology.
• Performs other duties as assigned.
PROFESSIONAL EXPERIENCE/QUALIFICATIONS:
• Minimum 5 years Pharmaceutical/Biotech programming experience including macro/tools development experience
• FDA submission experience is highly desirable.
• Strong SAS programming and Statistical background with strong skills in SAS Base, SAS/Macros, SAS/Graph and SAS/Stat.
• Ability to use professional concepts to achieve objectives in creative and effective ways.
• Solid knowledge of SAS Programming language, Software Development Life Cycle and CDISC standards (SDTM & ADaM).
• Solid knowledge of other software such as SpotFire, R Shinny etc. is a plus.
• BS/MS in Statistics, Math or Scientific Discipline
Required Skills:
STATISTICAL PROGRAMMING
FDA
LIAISON
LIFE CYCLE
PHARMACEUTICAL/BIOTECH
Additional Skills:
SAS
SOFTWARE DEVELOPMENT
SOFTWARE DEVELOPMENT LIFE CYCLE
SPOTFIRE
STATISTICS
AD HOC ANALYSIS
BIOMETRICS
BIOSTATISTICS
CASE REPORT
CASE REPORT FORM
CLINICAL STUDIES
CLINICAL TRIAL
COLLECTION
DATA ANALYSIS
DATA COLLECTION
DATA MANAGEMENT
DATA VALIDATION
DATASETS
DMS
DOCUMENTATION
DOCUMENTING
FORM DESIGN
MARKETING ANALYSIS
MICROSOFT WORD
ODS
OPERATIONAL DATA STORE
QUALITY CONTROL
SAP
SERIAL ATTACHED SCSI
SQL
STATISTICAL ANALYSIS
STRUCTURED SOFTWARE
TRAINING
WORD
XML
Kindly don't share fake resumes and fake copies for above roles, it wont works.
Babu S
Babu S
Hope you are doing great today...
Please Note:
If for any reason this does not interest you or you felt uncomfortable by any part of this email, I sincerely apologize. Please consider this E-mail as a request for referrals and feel free in forward this email to anyone whom you might find a fit.