[Hiring] Senior Statistical Programmer Analyst @Penumbra

Role Description

Under general supervision of a Statistics Project Manager or higher, prepares analysis programs to support the preparation and statistical analysis of clinical data. Works closely with other programmers, biostatisticians, and clinical data managers with a leading role in the collection, analysis, and reporting of clinical data for trials.

• 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.
• 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 Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures.
• Ensure other members of the department follow the QMS, regulations, standards and procedures.
• Perform other work-related duties as assigned.

Qualifications

• Bachelor's degree in Statistics, Computer Science or related field with 5+ years of statistical programming experience with 3+ years of experience in clinical statistical programming within medical device or related industry (biotechnology, pharmaceutical, Clinical Research Organization (CRO)) experience, or equivalent combination of education and experience.
• Familiarity with Base SAS, SAS/GRAPH, SAS/ODS, and SAS/STAT.
• SAS Certified Base and/or Advance Programmer experience is preferred.
• Experience with macro programming and SAS/SQL a plus.
• 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 a plus.
• Experience with regulatory submissions a plus.
• Knowledge of clinical data management systems, e.g., Oracle InForm and/or RAVE.
• Expertise at using SAS in Data Import, Data Manipulation, Data Analysis, and Data Export.
• Proficient in developing SAS/MACROS to access, extract, modify, merge, and analyze clinical data.
• Strong oral, written and interpersonal communications skills required.
• High degree of accuracy and attention to detail.
• Proficiency with MS Word, Excel and other standard office tools.

Requirements

• General office environment. Frequently required to stand, walk, sit, and reach with hands and arms, and to use a computer, sitting for extended periods.
• Specific vision abilities required by this assignment include ability to read, close vision, distance vision, color vision, peripheral vision, and depth perception.
• Approximately 10% travel to conferences and/or other Penumbra affiliated facilities.

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, 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).