Senior Statistical Programmer - REMOTE (Clinical) REF9000B
Company: ProPharma Group
Posted on: June 24, 2022
Company DescriptionProPharma 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
- 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 HaveQualifications
- 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.Additional InformationAll
candidates must be legally eligible to work in the United States.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
Keywords: ProPharma Group, Seattle , Senior Statistical Programmer - REMOTE (Clinical) REF9000B, IT / Software / Systems , Seattle, Washington
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