FULL_TIME

FEED

YEAR

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

Accreditation Standards

Biostatistics

Biotech and Pharmaceutical

Blog

Clinical Data

Clinical Research

Clinical Trial

Code of Federal Regulations

Communication Skills

Computer Programming

Consulting

Contract Research Organization (CRO)

Customer Relationship Management (CRM) Systems

Customer Satisfaction

Drug Development

Employee Retention

FDA Requirements

GCP (Good Clinical Practices)

ISO (International Organization for Standardization)

ISO 9001

LinkedIn

Medical Equipment

Medical Writing

Microsoft Office

Microsoft SharePoint

Needs Assessment

Problem Solving Skills

Project Estimates

Project/Program Management

Regulations

Regulatory Submissions

Sales Management

Sample Design

Scientific Principles

Statistics

Team Player

Vendor/Supplier Management

White Papers

Wireless Multimedia Messaging Service

partner JazzHR

UNKNOWN

ADAPTED_NOW

The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio.

Company Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description Purpose- The Senior Manager of Statistical Programming is a leadership role which manages a team of statistical programmers in the research and development of new pharmaceutical products. The Senior Manager of Statistical Programming is responsible for leading the statistical programming activities for one or more compounds/indications or a therapeutic area. This role must effectively interface with Statistics, Data Sciences, Medical Writing, Regulatory Publishing and Development Operations. Responsibilities- + Leads the statistical programming activities for one or more compounds/indications or a therapeutic area. + Manages a team of statistical programmers and the resource planning for their assigned projects. + Ensures timely deliverables, that all quality processes are followed and consistency within the projects. + Develops and oversees the development of SAS programs for the creation of ADaM data sets following CDISC standards. + Develops and oversees the development of SAS programs for the creation of Tables, Listings and Figures. + Ensures consistency of ADaM data sets for individual studies and integrated data. + Creates documentation for regulatory filings including reviewers guides and data definition documents. + Leads the development of standard SAS Macros and the development of standard operating procedures. + Manages, mentors and creates career development plans for assigned staff. + Participates in the recruitment and selection of new staff. Qualifications + MS in Statistics, Computer Science or a related field with 9+ years of relevant experience. OR BS in Statistics, Computer Science or a related field with 11+ years of relevant experience. + Minimum of 2 years experience leading a team of statistical programmers. + In-depth understanding of SAS programming concepts and techniques related to drug development. + In-depth understanding of CDISC Standards. + In-depth understanding of the drug development process, including experience with regulatory filings. + Ability to communicate clearly both oral and written. + Ability to effectively represent the Statistical Programming Organization in cross functional teams. + Ability to accurately estimate effort required for project related programming activities. Key Stakeholders • Directors of Statistics • Data Scientists • Medical Writers • Regulatory Publishers • Clinical Project Managers Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​ + The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. ​ + We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.​ + This job is eligible to participate in our short-term incentive programs. ​ + This job is eligible to participate in our long-term incentive programs​ Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html Salary: $121,000 - $230,000

AbbVie

Senior Manager, Statistical Programming - Oncology Early Development

Daiichi Sankyo Inc.

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

Mathematics

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 Analysis System (SAS)

Statistical Programming Languages

Statistics Software

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

HaleyMarketing

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Principal Biostatistician - RemoteMMS

Senior Manager, Statistical Programming - Oncology Early DevelopmentAbbVie

Study Design Statistician (Remote)MMS

Statistician/BiostatisticianLancesoft

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