General Summary
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. 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 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.
- Indicates an essential function of the role Position Qualifications
Minimum education and experience
- 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 Additional qualifications:
- 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 (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
- 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 Working Conditions
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. Base Pay Range Per Hour: $65.00 - $115.00
Individual compensation will vary based on factors such as qualifications, skill level, competencies, and work location.