Statistical Programmer Consultant

Kyverna

United States

Temporary

Posted 19 days ago

Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients suffering from autoimmune diseases. Guided by our core values, Stay True to Why, Collaborate to Accelerate, Lead with Clarity, Boldly Innovative, and Own the Outcome, we are committed to transforming the future of treatment for autoimmune disease. Join us at the forefront of cell therapy innovation and help redefine what’s possible.

Title: Statistical Programmer Consultant

Reports to: Director, Statistical Programming

Location: Remote (West coast hours preferred)

Duration: 6 months

Hours: 40/hrs per week

Hourly rate: $80-100/hr

Summary

We are seeking a Statistical Programmer Consultant to independently lead statistical programming activities and provide technical support for assigned clinical trial(s). This role combines study-level leadership, strong knowledge of clinical trial data, direct programming expertise to generate datasets, tables, listings, figures, and regulatory submission deliverables.

Responsibilities

Act as the lead programmer for assigned clinical trial(s), and work closely with study statistician, clinical data management, and other functions within the study team to provide expert input and statistical programming support.

Lead the strategic design, creation, mapping, and validation of comprehensive SDTM and ADaM datasets, ensuring flawless execution of data traceabilities.

Perform statistical analysis, program and validate Tables, Listings, and Figures (TLFs) using SAS to support Clinical Study Reports (CSRs), Development Safety Update Report (DSUR), ad-hoc requests, and publications.

Review and ensure high quality of CDISC packages including aCRF, SDTM/ADaM datasets, Pinnacle 21 reports, cSDRG/ADRG, and define XML meeting CDISC standards and regulatory requirements as part of eCTD submission.

Perform other duties as assigned.

Qualifications

Bachelor’s, Master’s in Statistics, Biostatistics, Computer Science, Mathematics, or a highly related Scientific discipline.

8+ years of statistical programing experience within a bio/pharma company, or clinical research organization (CRO).

Advanced proficiency in SAS (including complicated data steps, Macro language, and commonly used analysis procedures (e.g., PROC FREQ, PROC REPORT, PROC SQL, and PROC MIXED).

Comprehensive understanding of CDISC standards and experience generating regulatory package artifacts like define.xml and Reviewer's Guides (cSDRG, ADRG).

Strong communication, analytical, and problem-solving skills, with excellent time management and the ability to independently manage multiple high-priority projects in a fast-paced environment.

Excellent interpersonal skills and the ability to collaborate effectively as part of a cross-functional team.

Demonstrated ability to work independently, communicate proactively, and deliver results effectively in a remote work environment

Originally posted on Himalayas

Senior Statistical Programmer Analyst - T

Penumbra

United States

Full Time

Posted 21 days ago

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.