Who We Are:
We are an award-winning, dynamic, client-centric management consulting firm passionately committed to delivering outstanding results. Our mission is to provide comprehensive, cost-effective solutions that empower our clients to thrive. With a robust portfolio of management consulting, IT support, and staff augmentation services, we cater to a diverse clientele, spanning local, state, federal, and commercial sectors.

Our Commitment:
At Mfinite Consulting, our greatest asset is our dedicated team, who are wholeheartedly devoted to our clients. We take pride in offering on-site, world-class support, ensuring that our clients receive the best guidance and expertise available. Our unwavering focus is on enabling our clients to achieve remarkable, sustainable performance improvements and realize their strategic objectives.

Our Values:
We are proud to be a minority and veteran-owned small business. Our values reflect a deep-seated commitment to providing exceptional service and creating unparalleled value for our customers. We understand the importance of diversity and are honored to support the veteran community in the business world.

At Mfinite Consulting, we look forward to connecting and engaging with our LinkedIn community. Feel free to reach out, and let's explore how we can collaborate and help you achieve your business goals.

Industry: Business Consulting and Services
Company Size: 2-10 employees

Mfinite Consulting LLC

Savvy Admin PROD

**Location: ** Montgomery County, MD

**Job Type: ** Contract

**Overview**

Mfinite Consulting is seeking a **Library Technical Services Assistant ** to support cataloging, acquisitions, and digital resource management for a college library system.

**Responsibilities**

-  Maintain bibliographic and cataloging records within LMS

-  Manage MARC records and library metadata standards

-  Process purchase orders, invoices, and vendor communications

-  Maintain access to digital and online library resources

-  Update vendor knowledgebases and discovery systems

-  Support web-based content and resource platforms

**Qualifications**

-  Associate degree in Business, Accounting, Computer Science, or related field

-  2+ years of library experience preferred

-  Knowledge of library cataloging/classification systems

-  Strong technical and organizational skills

**Preferred**

-  Experience with OCLC Connexion

-  Knowledge of MARC, RDA, and Library of Congress standards

-  Academic/community college library experience

**About Mfinite Consulting:**

~~Mfinite Consulting is a certified minority-, woman-, and veteran-owned professional services firm delivering staffing, IT, and consulting solutions to government and commercial clients nationwide. ~~

Library Technical Services Assistant

Industry: Biotechnology Research
Company Size: 2-10 employees

Kolon TissueGene, Inc.

**ABOUT THE ROLE **

As a Senior Statistical Analyst within the Bioinformatics team at Kolon TissueGene, Inc., you will play a pivotal role in conducting and validating statistical analyses that underpin our clinical development programs. This position demands a rigorous command of statistical methodology and programming, combined with a commitment to data integrity, regulatory compliance, and cross-functional collaboration. You will work alongside internal teams and external vendors to ensure the highest standards of analytical quality across our clinical trials.

**This is a full-time, onsite (M-F) position in a laboratory/office environment, based in Rockville, MD. Hybrid schedule accommodations are not available at this time. **

**KEY RESPONSIBILITIES **

- **Statistical Analysis & Validation: **Conduct and validate statistical analyses for clinical trials, ensuring the accuracy and integrity of data outputs generated in-house or by vendors.

- **Publications & Abstracts: **Prepare analyses for scientific abstracts and peer-reviewed publications.

- **SOP & Regulatory Compliance: **Develop and uphold SOPs in alignment with regulatory guidelines including ICH E3, E6, and E9; ensure adherence to CDISC, SDTM, and CDASH data standards.

- **Programming: **Apply advanced SAS programming and develop standard macros and tools to support data analysis and reporting.

- **Statistical Methodology: **Apply advanced methodologies including regression, hypothesis testing, multivariate analysis, survival analysis, logistic regression, and missing data analysis.

- **Cross-Functional Collaboration: **Partner with clinical, regulatory, and commercial teams, as well as external vendors, to ensure high-quality analysis and programming outcomes.

- **Project Management: **Manage multiple concurrent projects, aligning statistical activities with program objectives and timelines.

- **Strategic Planning: **Interpret statistical results and actively participate in the strategic planning of analyses across the clinical development portfolio.

- **Innovation: **Stay current with emerging developments in statistics and statistical programming, contributing new methods and tools to the team.

**WHAT WE'RE LOOKING FOR **

The ideal candidate combines deep statistical expertise with hands-on programming skill and a sharp eye for data quality. You thrive in regulated clinical environments, communicate complex findings clearly, and take initiative in improving how analyses are designed and executed.

**REQUIREMENTS **

- Master's degree in Statistics, Biostatistics, Data Science, or a related field

- Minimum 5 years of experience in statistical analysis and programming, with proficiency in SAS and/or R

- Demonstrated expertise across a range of statistical techniques and methodologies

- Comprehensive knowledge of statistical programming processes, including development, review, and validation of database specifications and analysis outputs

- Experience preparing analyses for abstracts and scientific publications

- Working knowledge of regulatory guidelines (ICH E3, E6, E9) and data standards (CDISC, SDTM, CDASH)

- Experience collaborating with cross-functional teams and external vendors

- Demonstrated capability managing multiple projects and contributing to strategic planning of analyses

- Excellent oral and written communication skills

**CORE COMPETENCIES **

- Advanced proficiency in SAS statistical programming

- Strong statistical methodology knowledge: regression, hypothesis testing, multivariate, survival, logistic, and missing data analysis

- Deep understanding of clinical trial design, sampling estimation, and statistical inference

- Ability to manage multiple projects and prioritize effectively

- Strong attention to detail, accuracy, and analytical quality

- Clear communication and interpersonal skills for cross-functional collaboration

- Initiative and adaptability to new technologies and process improvements

- Commitment to compliance, integrity, and continuous professional development

**Physical Requirements **

- Must be able to push, pull, lift or carry up to 20 pounds occasionally.

- Must be able to engage in at least 30 minutes of moderate-intensity physical activity.

- Must be able to sit or stand for long periods.

**As we prepare for a pivotal U.S. launch, we are building a mission-driven team to shape the future of biotech — and improve the quality of life for patients worldwide. **

**Benefits Highlights **:

- Onsite yet Flexible work schedules

- Premium-free global health insurance (50% dependent coverage)

- 401(k) with immediate eligibility

- Long-term incentive bonuses

- On-site gym & wellness perks

- Extra PTO accrual every year

- Global and local training opportunities

**Equal Opportunity Employer **

Kolon TissueGene, Inc. is proud to be an **equal opportunity employer **. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration without regard to race, color, religion, gender, identity, sexual orientation, national origin, disability, or veteran status.

If you require a reasonable accommodation to participate in the application or interview process—such as completing an application, submitting materials, or attending an interview—please contact us at **hr@tissuegene.com **. All requests for accommodation will be handled confidentially and in accordance with applicable laws.

Senior Statistical Analyst

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