Dear Professional,

Hope you are doing great today...

This is Babu, BDM from Pantar Solutions INC, we are an Information
Technology and Business Consulting firm specializing in Project-based
Solutions and Professional Staffing Services. Please have a look at below
positions which is with our Clients and let me know if you are interested.
I would really appreciate if you share most recent updated resume for below
position:


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







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.


*Thanks & Regards,*

Babu
Pantar Solutions Inc
11605 N Community House Rd, Suite 102,
Charlotte NC 28277
Contact: 1 (704) 368-8464
E-Mail:  bab...@pantarsolutions.com

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