Senior Statistical Programmer Analyst - T

Penumbra, Inc.; Alameda (CA); On-site; USD 90,000 - 158,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

401(k) with match

Paid time off

Job summary

Penumbra, Inc. in Alameda, CA seeks a skilled Statistical Programmer to design and implement analysis datasets for regulatory submissions. You will develop SAS code, create datasets, and generate listings, tables, and graphs, while ensuring CDISC and FDA guidelines are followed.

The role involves mentoring junior programmers, collaborating with statisticians, data managers, and regulatory teams to ensure data integrity and timely delivery.

Qualifications

• Bachelor's degree and 5+ years in statistical programming; 3+ years in clinical programming within medical devices/pharma/ CRO.
• Familiarity with CDISC standards and regulatory submissions.

Responsibilities

• Develop algorithms and programs to create datasets.
• Produce data listings, summary tables and graphs using SAS.
• Check data listings, tables and graphs for accuracy.
• Import and export data; assist data management with data edits.
• Maintain CDISC guidance, FDA regulations, and industry trends.
• Prepare clinical trial datasets and programs for regulatory submission.
• Write analysis dataset specifications per SAP; mentor junior programmers.
• Act as SME on CDISC and good programming practices; build SAS macros libraries.
• Follow GCP, ICH, 21 CFR Part 11 and internal SOPs; support QMS compliance.
• Collaborate with regulatory affairs, QA, and external vendors.

Skills

SAS Base

SAS Macro

SAS/SQL

CDISC standards

Regulatory knowledge

Data analysis with SAS

GCP/ICH compliance

Communication

Education

Bachelor's degree in Statistics, Computer Science or related field

Tools

Base SAS

SAS/GRAPH

SAS/ODS

SAS/STAT

SAS Macros

SAS/SQL

Oracle InForm

RAVE

Job description

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.

What We Offer

• 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).

Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures, and markets novel products and has a broad portfolio that addresses challenging medical conditions in markets with significant unmet need. Penumbra sells its products to hospitals and healthcare providers primarily through its direct sales organization in the United States, most of Europe, Canada, and Australia, and through distributors in select international markets. The Penumbra logo is a trademark of Penumbra, Inc.

Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, age, disability, military or veteran status, or any other characteristic protected by federal, state, or local laws.

If you reside in the State of California, please also refer to Penumbra's Privacy Notice for California Residents.

For additional information on Penumbra's commitment to being an equal opportunity employer, please see Penumbra's AAP Policy Statement.