UNKNOWN

FEED

Proficiency with linear and non-linear modeling, mixed models, categorical and nonparametric methods, bootstrapping, multiple imputations, and sample size calculations. •Calculate clinical accuracy metrics (PPA, NPA, PPV, NPV) and deliver analyses to support regulatory filings.

Exact Shift - 8am-5pm, M-F, OT possible 
Duration of assignment - 6months, possible extension.Pay Range:$35.00 - $45.00 HourlyThis is a 100% remote role 
Job Description: Responsibilities 
•Write and review statistical analysis plans for analytical and clinical validation studies. 
•Apply DOE principles, conduct statistical analyses, and clearly communicate interpretations. 
•Calculate clinical accuracy metrics (PPA, NPA, PPV, NPV) and deliver analyses to support regulatory filings. 
•Generate tables, listings, and figures aligned with study protocols. 
•Review and QC statistical outputs from peers, ensuring scientific integrity. 
•Write and validate SAS code and macros to support standardized workflows. 
•Collaborate in cross-functional study teams, contributing data-driven insights that influence key decisions. 
•Partner with colleagues across functions to advance innovative diagnostics. Qualifications 
Education 
•BS in Statistics or Biostatistics + 5 years of experience, OR 
•MS in Statistics or Biostatistics + 1 year of experience, OR 
•PhD in Statistics or Biostatistics. 
•SAS programming certification is a plus. Experience 
•Proven experience as a statistician in IVD, medical devices, pharmaceutical, or life sciences settings. 
•Strong SAS (BASE, STAT, MACRO, GRAPH) programming Skills. 
•Experience analyzing complex data from multiple sources and familiarity with CLSI standards. 
•Knowledge of Next-Generation Sequencing (NGS) is a plus. Knowledge, Skills & Abilities 
•Solid understanding of statistical theory, experimental design, and clinical trial methodologies. 
•Proficiency with linear and non-linear modeling, mixed models, categorical and nonparametric methods, bootstrapping, multiple imputations, and sample size calculations. 
•Ability to manage multiple projects in a fast-paced environment. 
•Skill in translating scientific questions into practical, data-analytic solutions. 
•Excellent written and verbal communication skills —able to simplify complex ideas and build strong partnerships. 
•Flexibility to work across multiple time zones when needed. Employee Benefits: 
At LanceSoft, full time regular employees who work a minimum of 30 hours a week or more are entitled to the following benefits:
<ul><li>Four options of medical Insurance</li><li>Dental and Vision Insurance</li><li>401k Contributions</li><li>Critical Illness Insurance</li><li>Voluntary Permanent Life Insurance</li><li>Accident Insurance</li><li>Other Employee Perks</li></ul>About LanceSoft 
LanceSoft is rated as one of the largest staffing firms in the US by SIA. Our mission is to establish global cross-culture human connections that further the careers of our employees and strengthen the businesses of our clients. We are driven to use the power of our global network to connect businesses with the right people, and people with the right businesses without bias. We provide Global Workforce Solutions with a human touch.

We are a $125 Million, NMSDC-certified Minority & Woman owned Workforce Solutions Company headquartered in the DC metro area with presence across US with global presence - Canada, Mexico, India, UK, Malaysia, Indonasia, Hongkong, Singapore, UAE. We are specialized in providing Workforce Solutions, SOW project delivery, Engineering Solutions, Creative Services. We currently support 100+ Fortune companies globally and across multiple industry segments. We are currently supporting several massive programs across industry segment nationally/globally (Intel, Ally, AMD, QUALCOMM, Morgan Stanley, Kraft/ Mondelez, MNP, Amdocs, Dell, SanDisk, Medtronic, Becton Dickinson, GE, Lockheed Martin, UTC, L-3 Communications, Caterpillar, BMW, Mercedes Benz, National Grid, Dominion, Energy Future Holdings, PSEG, 3M, Fidelity, Aetna, Humana, Johnson & Johnson, Pfizer, Merck etc). 
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, identity, national origin, disability, or protected veteran status.

Lancesoft

Statistician/Biostatistician

Analysis Skills

Biology

Biostatistics

Biotech and Pharmaceutical

Clinical Trial

Clinical Validation

Communication Skills

Computer Programming

Cross-Functional

Data Analysis

Dental Insurance

Experiment Design

Health Insurance

Medical Equipment

Metrics

Mixed Linear Models

Multitasking

Net Present Value (NPV)

Network Connectivity

Next Generation Sequencing (NGS)

Presentation/Verbal Skills

Project/Program Management

Regulatory Submissions

Research Protocols

Statements on Auditing Standards (SAS)

Statistical Analysis System (SAS)

Statistical Quality Control

Statistics

United States Department of Energy (DOE)

Vision Plan

Writing Skills

HaleyMarketing

FULL_TIME

YEAR

Leads projects (all phases and even a program of studies) and smaller submissions, manages client meetings, CRMs, collaborates well with regulatory, PMs and sponsor. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive.

About MMSAre you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team? MMS is a award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research.Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit <a href="http://www.mmsholdings.com" rel="nofollow">www.mmsholdings.com</a> or follow MMS on <a href="https://www.linkedin.com/company/mms-holdings-inc-" rel="nofollow">LinkedIn</a>.Senior Biostatistician:Responsibilities: <ul><li>Create randomization and kit schedules independently, collaborate with sponsor, randomization and drug supply management teams.</li><li>Develop phase 1-4 SAPs and make significant contributions to iSAPs. Create SAP TLFs shells for all phases and studies.</li><li>Review ADAM and TLFs; work with client and programmers to resolve comments.</li><li>Strong programming and logic skills (working knowledge of SAS)</li><li>Ability to apply drug development knowledge during production of high quality statistical analyses.</li><li>Perform sample size calculations for a variety of scenarios and study designs.</li><li>Leads projects (all phases and even a program of studies) and smaller submissions, manages client meetings, CRMs, collaborates well with regulatory, PMs and sponsor.</li><li>Strong knowledge of CDISC (especially SDTM and ADaM), looks to understand guidance from FDA from the different therapeutical areas. </li><li>Understand the various tools that we work with</li><li>High level knowledge of drug development as it pertains to biostatistics.</li><li>Provides support to Data Safety Monitoring Boards (DSMB) by preparing and presenting output as the unblinded statistician.</li><li>Review the statistical section of a Sponsor’s protocol and ensure that the appropriate statistical methods are proposed for the study design and objectives. Provide valuable feedback to the Sponsor on the statistical aspects of the study. Create the statistical section of the Sponsor’s protocol with minimal support</li><li>High proficiency with MS Office applications</li><li>Demonstrate an understanding of project management-related tasks such as timelines, scope and resource requirement estimation.</li><li>Provide ICH guideline based input as applicable to statistics.</li><li>Prepare and review statistical methods and results sections for the CSR with minimal support in collaboration with in-house medical writers.</li></ul>Requirements:<ul><li>College graduate in Biostatistics, Statistics, or Mathematics discipline or related field, masters or PhD preferred, or many years of related experience required.</li><li>Minimum of 5 years’ experience in Biostatistics or similar field required.</li><li>Expert knowledge of scientific principles and concepts. </li><li>Has high level knowledge of drug development as it pertains to biostatistics; has the ability to apply drug development knowledge during production of high quality statistical analyses.</li><li>Strong SAS programming, SAS base, SAS macro experience.</li><li>Thorough knowledge and understanding of clinical data preferred.</li><li>Strong experience with data and production of TLGs.</li><li>Excellent scientific writing skills.</li><li>Strong resource for biostatistics; willing to guide others in a variety of biostatistical techniques.</li><li>Proficiency with MS Office applications.</li><li>Hands-on experience with clinical trial and pharmaceutical development preferred.</li><li>Good communication skills and willingness to work with others to clearly understand needs and solve problems.</li><li>Excellent problem-solving skills.</li><li>Good organizational and communication skills.</li><li>Familiarity with 21 CFR Part 11, FDA, and GCP requirements.</li><li>Basic understanding of CROs and scientific & clinical data/terminology, & the drug development process.</li></ul>Please consider your application unsuccessful if we do not reach out to you within 14 days of your submission.Powered by JazzHR

Senior Biostatistician - Remote (US)

Accreditation Standards

Clinical Data

Clinical Data Interchange Standards Consortium (CDISC)

Clinical Research

Code of Federal Regulations

Contract Research Organization (CRO)

Customer Relationship Management (CRM) Systems

Customer Satisfaction

Drug Development

Employee Retention

FDA (Food and Drug Administration)

FDA Requirements

GCP (Good Clinical Practices)

ICH Regulations

LinkedIn

Mathematics

Medical Writing

Microsoft Office

Needs Assessment

Organizational Skills

Problem Solving Skills

Project Estimates

Regulations

Sales Management

Scientific Principles

Team Player

Vendor/Supplier Management

Wireless Multimedia Messaging Service

partner JazzHR

Produce and present external company presentations providing industry visibility for the organization; Continually suggesting solutions to solve issues in tune with organizational direction. Lead complex projects, programs and submissions, manages client meetings, CRMs, collaborates well with regulatory, PMs and sponsors.

Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team? MMS is an award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research.   Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit <a href="http://www.mmsholdings.com/" rel="nofollow">www.mmsholdings.com</a> or follow MMS on <a href="https://www.linkedin.com/company/mms-holdings-inc-" rel="nofollow">LinkedIn</a>.Roles and Responsibilities<ul><li>Lead complex projects, programs and submissions, manages client meetings, CRMs, collaborates well with regulatory, PMs and sponsors.</li><li>Can develop SAPs and iSAPs text and shells with no supervision.</li><li>Produce and present external company presentations providing industry visibility for the organization; Continually suggesting solutions to solve issues in tune with organizational direction.</li><li>Can review or develop ADAM specifications; can work with programmers and junior statisticians to resolve comments.</li><li>High technical level, Subject Matter Expert in biostatistics; willing to guide others in a variety of biostatistical techniques.</li><li>Has the ability to apply drug development knowledge during production of complex statistical analyses.</li><li>Review or create the statistical section(s) of a Sponsor’s protocol and ensure that the appropriate statistical methods are proposed for the study design and objectives. Provide valuable feedback to the Sponsor on the statistical aspects of the study.</li><li>Prepare and review statistical methods and results sections for the CSR independently in collaboration with in-house medical writers.</li><li>Demonstrate an understanding of project management-related tasks such as timelines, scope and resource requirement estimation/management.</li><li>Perform sample size calculations for a variety of scenarios and study designs. Can provide statistical consulting support to sponsors re study design and sample size calculations.</li><li>Ability to create randomization and kit schedules independently, collaborate with sponsor, randomization and drug supply management teams.</li><li>Understand the various tools that we work with and able to use them correctly (for SCM: checks in/out; use of external SharePoint).</li><li>Provide support to Data Safety Monitoring Boards (DSMB) by preparing and presenting output as the unblinded statistician.</li><li>Is familiar with and stays current with the latest industry practices and updated regulatory guidelines.</li><li>Write blogs and/or white papers for posting on the company website.</li></ul><div>Requirements<ul><li>Masters in Biostatistics, Statistics discipline or related field, or related experience, PhD preferred.</li><li>Minimum of 7 years’ experience in Biostatistics, Statistics or similar field required.</li><li>Submission experience (ISS/ISE).</li><li>Has high level knowledge of drug development as it pertains to biostatistics.</li><li>Expert knowledge of scientific principles and concepts. </li><li>Good communication skills and willingness to work with others to clearly understand needs and solve problems.  </li><li>Good organizational skills.</li><li>High proficiency with MS Office applications.        </li><li>Hands-on experience with clinical trial and pharmaceutical development preferred.</li><li>Excellent problem-solving skills.        </li><li>Familiarity with current ISO 9001 and ISO 27001 standards preferred.            </li><li>Familiarity with 21 CFR Part 11, FDA, and GCP requirements.</li><li>Good understanding of CROs and scientific & clinical data/terminology, & the drug development process.</li></ul></div>Powered by JazzHR

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Statistician/Biostatistician Lancesoft

Senior Biostatistician - Remote (US) MMS

Principal Biostatistician - Remote MMS

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