FULL_TIME

FEED

YEAR

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)

Accreditation Standards

Algorithms

Analysis Skills

Bayesian Networks

Biostatistics

Biotech and Pharmaceutical

Clinical Data

Clinical Research

Clinical Trial

Cloud Computing

Computer Programming

Contract Research Organization (CRO)

Cost Estimates

Customer Satisfaction

Customer Support/Service

Data Analysis

Data Visualization

Drug Development

Employee Retention

Experiment Design

Intellectual Property Development

LinkedIn

Marketing

Mathematics

Medical Equipment

Medicine

Needs Assessment

Pharmacology

Physics

Pre-Sales

Product Demonstration

Product Development

Protocol Design

Quality Metrics

R Programming Language

Regulatory Submissions

Reporting Skills

Research Protocols

Sales Support

Simulation

Software Simulation

Statistical Analysis System (SAS)

Statistical Programming Languages

Statistics

Statistics Software

Team Player

White Papers

Wireless Multimedia Messaging Service

partner JazzHR

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)

Clinical Data Interchange Standards Consortium (CDISC)

Code of Federal Regulations

Communication Skills

Customer Relationship Management (CRM) Systems

FDA (Food and Drug Administration)

FDA Requirements

GCP (Good Clinical Practices)

ICH Regulations

Medical Writing

Microsoft Office

Organizational Skills

Problem Solving Skills

Project Estimates

Project/Program Management

Regulations

Sales Management

Scientific Principles

Vendor/Supplier Management

Writing Skills

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 Jobs in Indianapolis, IN

Study Design Statistician (Remote) MMS

Senior Biostatistician - Remote (US) MMS

Principal Biostatistician - Remote MMS

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