Senior Statistical Programmer Analyst - T

Penumbra

1d•$65 - $115

About The Position

Under 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. The role works closely with programmers, biostatisticians, and clinical data managers, and has a leading role in collecting, analyzing, and reporting clinical trial data. The position develops programs and algorithms to create datasets; produces and independently checks listings, tables, and graphs; supports data import and export and data-cleaning activities; and prepares clinical trial datasets and programs for regulatory submission. It writes specifications for analysis datasets in accordance with statistical analysis plans and works with project statisticians and other project-team programmers. The role also manages a clinical study data warehouse, interacts with regulatory affairs, quality assurance staff, and external clinical system vendors, mentors less experienced programmers, and serves as a subject matter expert in CDISC and good statistical programming practices. It builds SAS coding and macro libraries and performs work consistent with applicable clinical, quality, and regulatory requirements, including GCP, ICH, 21 CFR Part 11, internal procedures, and international regulations. The position is based in a general office environment and includes approximately 10% travel to conferences and/or other Penumbra-affiliated facilities. The stated base pay range is $65.00–$115.00 per hour; individual compensation varies based on qualifications, skills, competencies, and work location.

Requirements

Bachelor’s degree in Statistics, Computer Science, or a related field, with 5 or more years of statistical programming experience and 3 or more years of clinical statistical programming experience in the medical device or a related industry (biotechnology, pharmaceutical, or CRO), or an equivalent combination of education and experience.
Familiarity with Base SAS, SAS/GRAPH, SAS/ODS, and SAS/STAT.
Ability to handle multiple tasks.
Ability to identify ways to improve business performance and advocate for improvements when necessary.
Knowledge of international regulations, requirements, and guidance associated with clinical data standards and clinical databases used for regulatory submissions.
Knowledge of clinical data standards, including CDASH, SDTM, ADaM, SHARE, BRIDG, ODM, Define, and controlled terminology.
Knowledge of clinical data management systems such as Oracle InForm and/or RAVE.
Expertise using SAS for data import and preprocessing; data manipulation using SAS data steps, procedures, arrays, loops, merges, PROC SQL, PROC SORT, and PROC TRANSPOSE; data analysis using specified SAS statistical procedures; and data export and reporting using PROC REPORT, PROC SGPLOT, and SAS/ODS.
Proficiency developing SAS macros to access, extract, modify, merge, and analyze clinical data.
Strong oral, written, and interpersonal communication skills.
High degree of accuracy and attention to detail.
Proficiency with MS Word, Excel, and other standard office tools.

Nice To Haves

SAS Certified Base and/or Advanced Programmer experience.
Experience with macro programming and SAS/SQL.
Experience with a metadata repository in clinical data.
Experience with regulatory submissions.

Responsibilities

Develop algorithms and write programs to create datasets according to specifications.
Produce data listings, summary tables, and graphs using analysis software.
Independently check data listings, summary tables, and graphs.
Import and export data.
Assist the data management group with data-edit checks to facilitate data cleaning.
Keep current with CDISC guidance and implementation guides, FDA guidance and regulations for electronic data submissions, and industry trends in data mapping, data management, standards compliance, metadata management, and data warehousing.
Prepare clinical trial datasets and programs for regulatory submission.
Write analysis-dataset specifications following the statistical analysis plan.
Interact with the project statistician and other programmers on project teams.
Manage the data warehouse used to maintain libraries of clinical study data.
Interact with regulatory affairs, quality assurance staff, and external clinical system vendors.
Mentor less experienced statistical programmers.
Serve as a subject matter expert on CDISC and good statistical programming practices.
Build efficient SAS coding and macro libraries.
Conduct work consistent with GCP, ICH, 21 CFR Part 11, internal SOPs and training, and international regulatory requirements.
Adhere to the Company’s Quality Management System and applicable domestic and global quality-system regulations, standards, and procedures.
Ensure other department members follow the QMS, regulations, standards, and procedures.
Perform other work-related duties as assigned.

Benefits

Medical insurance.
Dental insurance.
Vision insurance.
Life insurance.
Accidental death and dismemberment insurance.
Short- and long-term disability insurance.
401(k) with employer match.
Paid parental leave.
Eleven paid company holidays per year.
At least fifteen days of accrued vacation per year, increasing with tenure.
Paid sick time in compliance with applicable laws.
Collaborative teamwork environment with ongoing learning and performance rewards.