REMOTE Senior Statistical Programmer - REMOTE (Clinical) REF9000B
Company: ProPharma Group
Posted on: November 25, 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 environment preferred.
- 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, Irvine , REMOTE Senior Statistical Programmer - REMOTE (Clinical) REF9000B, Healthcare , Irvine, California
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