Penumbra, Inc.
healthcare
SeniorStatisticalProgrammer
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“Senior Statistical Programmer at Penumbra, Inc.. Skills: Statistical programming, SAS programming, CDISC standards, Clinical data analysis, Regulatory submissions. Prepares analysis programs to support the preparation and statistical analysis of clinical data. Coordinates the statistical programming activities for multiple clinical projects”
Industry & Context.
Business travel from 0% - 10%, Requires some lifting and moving of up to 25 pounds, Requires the employee to be frequently able to stand, walk, sit, and reach with hands and arms, Requires the employee to use a computer, sitting for extended periods, Specific vision abilities required by this job include the ability to read, close vision, distance vision, color vision, peripheral vision, and depth perception
What They're Looking For.
Must Have
Bachelor's degree in statistics, computer science, or similar quantitative field, 5+ years statistical programming experience, 3+ years of experience in clinical statistical programming within medical device or a related industry (biotechnology, pharmaceutical, Clinical Research Organization (CRO)), Understanding of GCP, ICH, 21 CFR part 11, internal SOPs and training, and international regulatory requirements, Adherence to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures, Understanding of relevant security, privacy and compliance principles and adherence to applicable regulations, standards, and procedures
Nice to Have
SAS Certified Base and/or Advance Programmer experience, Experience with macro programming and SAS/SQL, Experience with metadata repository in clinical data, Experience with regulatory submissions, Knowledge of clinical data management systems, e. g. , Oracle InForm and/or RAVE
What You'll Do.
Prepares analysis programs to support the preparation and statistical analysis of clinical data
Coordinates the statistical programming activities for multiple clinical projects
Ensures internal consistency of output
Assesses consistency with other projects and activities
Develops algorithms and writes programs to create datasets
Produces data listings
summary tables and graphs using analysis software
Imports and exports data
Prepares clinical trial datasets and programs for regulatory submission
Writes specifications for analysis datasets
Manages the data warehouse used to manage libraries of clinical study data
Builds efficient SAS coding and macro libraries
How You'll Work.
Team & Collaboration
Interacts with the project statistician and other programmers participating on a project team; Interact with regulatory affairs, quality assurance staff, and external clinical system vendors; Ensure other members of the department follow the QMS, regulations, standards, and procedures
Communication Scope
Good communication skills
Process & Methodology
Coordinates the statistical programming activities for multiple clinical projects
Full Job Description
## Description General Summary Under the general supervision of a Statistics Project Manager or higher, the Senior Statistical Programmer Analyst prepares analysis programs to support the preparation and statistical analysis of clinical data, coordinates the statistical programming activities for multiple clinical projects, ensures internal consistency of output, and assesses consistency with other projects and activities. Specific Duties and Responsibilities •Following specifications, develops algorithms and writes programs to create datasets. * •Produces data listings, summary tables and graphs using analysis software. * •Independently checks data listings, summary tables and graphs. * •Imports and exports data. * •Assists data management group in performing data edit checks to facilitate data cleaning. •Maintains complete and in-depth understanding of all Clinical Data Interchange Standards Consortium (CDISC) guidance documents and implementation guides, as well as FDA guidance and regulations regarding electronic submission of data. Keeps abreast of industry trends in data mapping, data management, standards compliance methodologies, metadata management and data warehousing. * •Prepares clinical trial datasets and programs for regulatory submission. •Following statistical analysis plan, writes specifications for analysis datasets. •Interacts with the project statistician and other programmers participating on a project team. •Manage the data warehouse used to manage libraries of clinical study data. •Interact with regulatory affairs, quality assurance staff, and external clinical system vendors. •Mentors less experienced statistical programmers. •Act as the subject matter expert on CDISC and good statistical programming practices. •Builds efficient SAS coding and macro libraries. •Understands and conducts work consistent with GCP, ICH, 21 CFR part 11, internal SOPs and training, and international regulatory requirements. * •Adhere to the Company’s Quality Manage
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