Senior Statistical Programmer (Clinical)
Company: ProPharma Group
Location: Western Springs
Posted on: May 16, 2022
ProPharma Group is an industry leading, single source provider for
regulatory compliance, pharmacovigilance, and medical information
services across the full development lifecycle for pharmaceutical,
biotechnology, and medical device companies. Operating around the
world with offices in Australia, Canada, Germany, Japan, the
Netherlands, Sweden, United Kingdom, and the United States,
ProPharma Group's fully integrated service offerings will provide
clients with a comprehensive suite of global support services that
are required to be competitive in today's dynamic markets. We build
successful long-term relationships with clients by providing
leading industry knowledge, experience, and proven processes.
Essential Functions Include
Providing statistical programming and validation for clinical study
reports, final/interim analyses, meetings, other types of analyses,
and reports throughout the project.
Serves as a lead SAS/Statistical Programmer on ProPharma Group
Coordinating programming activities among the study programmers to
achieve timely deliveries in the following areas: SDTM datasets,
ADaM or analysis datasets, statistical tables, listings, and
figures (TLFs), data reconciliation reports, and other internal and
Reviewing, updating, improving, and creating new standard program
templates and macros to be used by programmers across the
department to increase efficiency and consistency.
Reviewing and providing suggestions to department management for
updates to SOPs and Work Instructions, and writing/updating
specified documents as assigned.
Accessing and converting data to SAS datasets and other file types
from the database management system and PC file formats (e.g.,
Microsoft Excel, text files).
Working with external vendors to develop and/or monitor the content
and structure of SAS datasets and other files.
Overseeing programming activities by external vendors (e.g.,
Working closely with statisticians and other statistical
programmers to generate and validate TLF outputs; review data
specifications to ensure accuracy and ensure the quality and
soundness of statistical programming algorithm.
Providing input in developing specifications of tabulation and
analysis datasets, validation plans, and other related
Reviewing data submission packages including define files and data
reviewers guide documents.
Working independently to accomplish tasks and goals defined by
supervisor as well as suggesting new ideas to improve the
Mentoring less-experienced statistical programmers.
Qualified Candidates Must Have
Minimum: Bachelor's degree in Statistics, Computer Science,
Mathematics, or a related discipline, or a combination of other
education with applicable professional experience.
Minimum 5 years' experience in SAS/statistical programming,
preferably for clinical trials in a pharmaceutical/CRO
Project leadership experience in a pharmaceutical/CRO programming
Experience using Base SAS, SAS/Macro, SAS/ACCESS, SAS/STAT,
Microsoft Word, and Microsoft Excel. Experience with SAS ODS
Experience following CDISC data standards (e.g., SDTM, ADaM)
Understanding of FDA, PMDA, and ICH guidelines preferred.
Good organization, time management, and attention to detail needed
to work in a fast-paced environment under tight deadlines while
maintaining focus on details and quality.
Applies good judgment and demonstrates initiative to resolve
Strong written and interpersonal communication skills needed to
work effectively in a team environment.
All candidates must be legally eligible to work in the United
We are an equal opportunity employer. M/F/D/V
***ProPharma Group does not accept unsolicited resumes from
recruiters/third parties. Please, no phone calls or emails to
anyone regarding this posting.***
Keywords: ProPharma Group, Chicago , Senior Statistical Programmer (Clinical), IT / Software / Systems , Western Springs, Illinois
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