FULL_TIME

FEED

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

Biostatistics

Biotech and Pharmaceutical

Clinical Data

Clinical Data Interchange Standards Consortium (CDISC)

Clinical Research

Clinical Trial

Code of Federal Regulations

Communication Skills

Computer Programming

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 Equipment

Medical Writing

Microsoft Office

Needs Assessment

Organizational Skills

Problem Solving Skills

Project Estimates

Project/Program Management

Regulations

Regulatory Submissions

Sales Management

Scientific Principles

Statistical Analysis System (SAS)

Statistics

Team Player

Vendor/Supplier Management

Wireless Multimedia Messaging Service

Writing Skills

partner JazzHR

Working alongside innovative statisticians you will be responsible for leading the full life-cycle of KerusCloud support and statistical services, from: Assisting customers with their study design with a particular focus on simulation with KerusCloud to ensure they are aligned with the study objectives. As part of our Strategic Statistical Services Arm, this is a full-time role with emphasis on being an internal and external SME for clinical trial design, together with providing consultation to advise clients on a range of broader statistical issues, and will have an internal job title of Strategic Statistician.

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 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>. As part of our Strategic Statistical Services Arm, this is a full-time role with emphasis on being an internal and external SME for clinical trial design, together with providing consultation to advise clients on a range of broader statistical issues, and will have an internal job title of Strategic Statistician.Job Description:Our experienced statisticians and programmers develop intellectual property and assets to support the design and analysis of clinical trials, precision medicine and real-world data analytics. We address the emerging analytics needs of the Industry with our biostatistics services, bespoke algorithms and unique, state of the art, proprietary, cloud-based trial simulation software KerusCloud. Working alongside innovative statisticians you will be responsible for leading the full life-cycle of KerusCloud support and statistical services, from:<ul><li>Assisting customers with their study design with a particular focus on simulation with KerusCloud to ensure they are aligned with the study objectives.</li><li>Preparation of study protocols and development of Statistical Analysis Plans and Statistical Analysis Reports.</li><li>Summarize, analyze and visualize study data using a variety of statistical methods, ultimately delivering results to an agreed timeline with optimal quality.</li><li>Provide statistical consultancy support to sponsors across the full span of clinical development, including oversight of third-party statistical and programming deliverables.</li><li>Maintain current knowledge of relevant research techniques such as modelling, simulation and experimental design and participate in continuous professional development activity.</li><li>Support pre-sales discussions to understand and identify client needs, then contribute to technical solutions and resource/ cost estimates.</li><li>Collaborate with the Product Development team defining key features and statistical aspects of KerusCloud.</li><li>Provide input and support to Marketing of KerusCloud, including demonstrations to clients, white papers, etc.</li></ul>Requirements:<ul><li>Bachelors degree in mathematics, statistics, physics, pharmacology or with a strong statistical component, Masters or PhD preferred.</li><li>5-7 years of experience in the application of medical statistics (pharma, CRO, academic).</li><li>Willingness to engage with clients to understand and research problems and provide creative, business-orientated solutions.</li><li>Experience in delivering customer projects to high quality standards.</li><li>Experience in SAS and/ or R statistical software packages.</li><li>Experience in study design and protocol and report-writing preferred.</li><li>Experience of modelling and simulation techniques to explore complex study designs preferred.</li><li>Experience of Bayesian approaches to design and analysis of clinical data preferred.</li><li>Experience of early-phase drug development processes including innovative/ adaptive study design preferred. </li></ul>Powered by JazzHR

Study Design Statistician (Remote)

Algorithms

Analysis Skills

Bayesian Networks

Cloud Computing

Cost Estimates

Customer Support/Service

Data Analysis

Data Visualization

Experiment Design

Intellectual Property Development

Marketing

Medicine

Pharmacology

Physics

Pre-Sales

Product Demonstration

Product Development

Protocol Design

Quality Metrics

R Programming Language

Reporting Skills

Research Protocols

Sales Support

Simulation

Software Simulation

Statistical Programming Languages

Statistics Software

White Papers

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

Principal Biostatistician - Remote

Blog

Consulting

ISO (International Organization for Standardization)

ISO 9001

Microsoft SharePoint

Sample Design

UNKNOWN

ADAPTED_NOW

Other preferred skills include the following: At least one (1) years' experience in the application of M&S to Decision Analysis problems; At least one (1) years' experience in the application of M&S to Cost/Benefit Analysis problems; At least one (1) years' experience in using at least five (5) of the these: R, Python, EXCEL/VBA, ARENA, OCTAVE, Tableau, Gurobi/CPLEX, EXTEND SIM, SAS, NETICA, statsmodels, Stata, MATLAB, SPSS. The Operations Research Analyst analyzes management and operational problems and formulates mathematical or simulation models of problems for solution by computers or other methods.

<h2>Overview</h2>At ITA International, we’re a tech-enabled professional services company. Headquartered in Newport News, Virginia, we leverage subject matter expertise, data analytics and technology to challenge boundaries and transform possibilities.  With a global presence and a passionate team of over 200 ITAers, we’re driven by mission success for our customers, “In The Arena.” Our expertise spans Operations, Training, Engineering, Nanotechnology, Statistics, Machine Learning and Software Engineering – enabling data and tech-enabled solutions that deliver real value.  Join our impactful journey at ITA International. As Theodore Roosevelt said, “The credit belongs to the man who is actually in the arena.” We’re here, standing beside our customers, ready to serve and succeed.  ITA is seeking an Operations Research Analyst to join the team at Fort Meade in Annapolis Junction, MD.<h2>Responsibilities</h2>The Operations Research Analyst analyzes management and operational problems and formulates mathematical or simulation models of problems for solution by computers or other methods. They define data requirements, gather and validate information, as well as apply judgment and statistical tests.  The Operations Research Analyst performs verification and testing of model to ensure adequacy, or determines the need for reformulation. They also prepare reports defining the problem, evaluation, and possible solutions. The analyst also assists in evaluating implementation and effectiveness of research. In addition, they assist in the design, conduct and evaluation of operational models where limited data exists to formulate a model. On occasion, the Operations Research Analyst will develop technical trainings to help enrich the skills set of the client personnel as well as help support other project teams. The analyst will also conduct data elicitation sessions and project scoping meetings as needed. Lastly, the analyst prepares summary briefings that describe project problem statements, modeling approaches and proposed solutions as well as participate in regular customer engagement.<h2>Qualifications</h2>The ideal candidate must have a TS/SCI security clearance. The candidate must also have 1 of the following backgrounds:<ul><li>Bachelors degree from an accredited college or university in Operations Research, Industrial Engineering, or Management Science. At least five (5) years of experience in conducting analyses of management and operational problems using Operations Research techniques is required; or </li><li>Master’s degree from an accredited college or university in Operations Research, Industrial Engineering, or Management Science. At least three (3) years of experience in conducting analyses of management and operational problems using Operations Research techniques is required; or </li><li>Doctorate degree from an accredited college or university in Operations Research, Industrial Engineering, or Management Science. At least one (1) years of experience in conducting analyses of management and operational problems using Operations Research techniques is required. </li></ul>Other preferred skills include the following:<ul><li>At least one (1) years' experience in the application of M&S to Decision Analysis problems; </li><li>At least one (1) years' experience in the application of M&S to Cost/Benefit Analysis problems; </li><li>At least one (1) years' experience in using at least five (5) of the these: R, Python, EXCEL/VBA, ARENA, OCTAVE, Tableau, Gurobi/CPLEX, EXTEND SIM, SAS, NETICA, statsmodels, Stata, MATLAB, SPSS.</li><li>Experience in a few of the following areas: <ul><li>Gathering data needed to run models</li><li>Developing mathematical or simulation modeling prototypes </li><li>Preparing reports defining the problem, its evaluation, and possible solutions</li><li>Designing and evaluating operational models where limited data is available</li><li>Proposing potential mathematical or simulation modeling approaches to be applied to a specific problem</li><li>Conducting analyses of management and operational problems</li><li>Formulating mathematical or simulation models of problems for solution by computers or other methods</li><li>Applying statistical tests to validate information </li></ul></li></ul><h2>Benefit and Compensation Transparency</h2>ITA International proudly complies with all federal and state benefit and pay transparency laws. Employees of ITA can expect a robust benefit package, including:<ul><li>Medical, dental and vision plans</li><li>Life Insurance</li><li>Short Term Disability insurance (where applicable)</li><li>Voluntary ancillary benefit options</li><li>401k retirement benefits with employer matching contributions</li></ul><h2>Application and Employment at ITA International</h2>ITA International is an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.In compliance with the ADA Amendments Act (ADAAA), ITA International would like to ensure that your application process goes as smoothly as possible. If you would like to preview the physical requirements for this position, or if you have a disability and would like to request an accommodation in order to apply for a currently open position with ITA, please contact us by phone at 757-246-6781 or email us at HR@ita-intl.com.

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Senior Biostatistician - Remote (US) MMS

Study Design Statistician (Remote) MMS

Principal Biostatistician - Remote MMS

Operations Research Analyst ITA International

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