Senior Statistical Programmer Analyst

Summary

Join Penumbra as a Senior Statistical Programmer Analyst and contribute to the preparation and statistical analysis of clinical data under the guidance of a Statistics Project Manager. You will develop algorithms, write programs to create datasets, produce data listings, and ensure data consistency across multiple clinical projects. This role requires strong SAS programming skills, experience with CDISC standards, and collaboration with statisticians and other team members. You will also be responsible for managing data warehouses and mentoring junior programmers. The position offers a competitive salary and a comprehensive benefits package.

Requirements

Bachelor’s degree in statistics, computer science, or similar quantitative field, with 5+ years statistical programming experience and 3+ years of experience in clinical statistical programming within medical device or a related industry (biotechnology, pharmaceutical, Clinical Research Organization (CRO)), or an equivalent combination of relevant education and applicable job experience

Responsibilities

• Following specifications, develop algorithms and write programs to create datasets
• Produce data listings, summary tables and graphs using analysis software
• Independently check data listings, summary tables and graphs
• Import and export data
• Assist data management group in performing data edit checks to facilitate data cleaning
• Maintain 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. Keep abreast of industry trends in data mapping, data management, standards compliance methodologies, metadata management and data warehousing
• Prepare clinical trial datasets and programs for regulatory submission
• Following statistical analysis plan, write specifications for analysis datasets
• Interact 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
• Mentor less experienced statistical programmers
• Act as the subject matter expert on CDISC and good statistical programming practices
• Build efficient SAS coding and macro libraries
• Understand and 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 (QMS) as well as domestic and global quality system regulations, standards, and procedures
• Understand relevant security, privacy and compliance principles and adhere to the regulations, standards, and procedures that are applicable to the Company
• Ensure other members of the department follow the QMS, regulations, standards, and procedures
• Perform other work-related duties as assigned

Preferred Qualifications

• Familiarity with Base SAS, SAS/GRAPH, SAS/ODS, and SAS/STAT
• SAS Certified Base and/or Advance Programmer experience
• Experience with macro programming and SAS/SQL
• Good communication skills and attention to detail
• Proven ability to handle multiple tasks
• Able to identify ways to improve business performance and campaigning for it when necessary
• Knowledge of international regulations, requirements and guidance associated with clinical data standards and clinical databases used for regulatory submission
• Knowledge of clinical data standards including CDASH, SDTM, ADaM, SHARE, BRIDG, ODM, Define and controlled terminology
• Experience with metadata repository in clinical data
• Experience with regulatory submissions
• Knowledge of clinical data management systems, e.g., Oracle InForm and/or RAVE
• Expertise at using SAS in Data Import (extracting the raw data from data warehouse with SAS/ACCESS and performing data pre-processing for particular statistical analysis), Data Manipulation (using SAS data steps and PROCs to modify datasets and transform, generate, and process data with array, do loop, merge, PROC SQL, PROC SORT, PROC TRANSPOSE, etc.); Data Analysis (analyze data using PROC MEANS, PROC FREQ, PROC UNIVARIATE, PROC TTEST, PROC GLM, PROC LOGISTIC, PROC LIFETEST, PROC PHREG); Data Export: generate output with PROC REPORT, PROC SGPLOT, SAS/ODS; Graphs (Kaplan-Meier plot, box plot, bar chart, water-fall plot, forest plot, shift plot, life table, prevalence plot, etc.)
• Proficient in developing SAS/MACROS to access, extract, modify, merge, and analyze clinical data

Benefits

• A collaborative teamwork environment where learning is constant, and performance is rewarded
• The opportunity to be part of the team that is revolutionizing the treatment of some of the world's most devastating diseases
• A generous benefits package for eligible employees that includes medical, dental, vision, life, AD&D, short and long-term disability insurance, 401(k) with employer match, an employee stock purchase plan, paid parental leave, eleven paid company holidays per year, a minimum of fifteen days of accrued vacation per year, which increases with tenure, and paid sick time in compliance with applicable law(s)