Jobs
>
Bridgewater

    Associate Director, Biostatistics - Bridgewater, United States - Everest Clinical Research

    Everest Clinical Research
    Everest Clinical Research Bridgewater, United States

    3 weeks ago

    Default job background
    Description


    Everest Clinical Research ("Everest") is a full-service contract research organization (CRO) providing a broad range of expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries.

    We serve some of the best-known companies and work with many of the most advanced drugs, biologics, and medical devices in development today.

    Everest has been an independent CRO since 2004 with a strong foundation as a statistical and data management center of excellence.

    Building on this foundation, Everest has successfully developed and established itself as a full-service CRO.

    Everest's headquarters are located in Markham (Greater Toronto Area), Ontario, Canada with additional sites in Bridgewater (Greater New York City Area), New Jersey, USA, Shanghai (Pudong Zhangjiang New District), China and Taipei, Taiwan.


    Quality is our backbone, customer-focus is our tradition, flexibility is our 's 's Everest.

    To drive continued success in this exciting clinical research field, we are seeking a committed, skilled, and customer-focused individual to join our winning team as Associate Director, Biostatistics (Statistical Operations) for our Bridgewater, New Jersey, USA on-site location, or remotely from a home-based office anywhere in the USA in accordance with our Work from Home policy.



    Key Accountabilities:

    Work with a Director, Senior Director, and/or Executive Director of Biostatistics, Statistical Operations, or Biometrics to manage clinical trial programs/projects from one or multiple clients.

    Provide day-to-day technical and operational leadership to project teams supporting these programs/projects.

    Coach, mentor, develop, provide technical review, and provide advice and expertise to direct subordinate Biostatisticians and Statistical Programmers, as well as indirect subordinate Biostatisticians and Statistical Programmers assigned to the program/projects.

    Perform semi-annual and annual performance review and develop developmental plans for direct subordinates and, where appropriate, indirect subordinates through contributing to the performance evaluation process.

    Lead statistical and programming teams, interact with clients and/or Everest internal project leaders to plan and implement statistical and programming project plans, and deliver quality deliverables.

    Ensure sound statistical methodologies in the study design, sample size estimation, statistical analysis planning, data handling, statistical modeling, testing, analysis, and reporting.


    Provide statistical input in protocol design and development. Participate in the writing of trial protocols and research proposals.

    Serve as a principal level Biostatistician, working effectively with interdisciplinary teams to contribute strategically (through innovative ideas or applications) to drug development and commercialization at the study and drug compound/therapeutic areas levels.

    Review and provide input to clinical data management deliverables, including but not limited to the following: electronic Case Report Forms (eCRFs), eCRF Completion Instructions, data validation specifications, Data Review Plan (and the ongoing data review tables, listings, and figures in accordance with the Plan), and Data Management Plan (DMP).


    Write Statistical Analysis Plans (SAPs), Statistical Reports, and statistical methodologies sections of Clinical Study Reports (CSRs). Perform peer review of SAPs and other technical documents written by others.

    Perform hands-on statistical analysis and modeling; maintain expertise in state-of-the-art statistical methodology and regulatory requirements.

    Validate core statistical tables, listings, and figures programmed by Statistical Programmers and/or Biostatisticians, ensuring that core results for each responsible trial are complete and accurate.

    Perform overall quality control (QC) review on statistical deliverables before they are released to the clients.

    Review and confirm ADaM dataset specifications. Perform QC activities on ADaM datasets programmed by other Statistical Programmers and Biostatisticians.

    Provide statistical consultation to medical and clinical trial personnel for the publication of trial results, and participate in the writing of abstracts, manuscripts, posters, and presentations.


    Act as a consultant to less experienced Biostatisticians.

    Ensure all study level as well as drug program level statistical and programming activities are conducted in compliance with relevant regulatory requirements and applicable standards/conventions.


    Interact with regulatory agencies and support Sponsor in new drug application.

    This includes participating as a statistical liaison to the regulatory agency on behalf of the Sponsor company and ensuring documentation, statistical results, and study datasets meet the regulatory agency's requirement/expectation (e.g., CDISC).


    Perform statistical and programming resource management, capacity analysis, benchmarking, and generation of performance metrics. Participate in the continuous improvement and maintenance of statistical and programming governing documents.

    Contribute to organization development and growth by participating in the interview and evaluation process for professional applicants.

    Assist in business development activities, including but not limited to the following: provide cost estimates of statistical and programming services; participate in generation of project proposals and bid defense meetings; and participate in professional trade shows when required.


    Participate and/or assist in statistical and programming project budget planning, tracking, and reporting.

    Perform tracking of out-of-scope services on assigned projects, provide cost estimates, and draft change orders to existing services work orders.



    Qualifications and Experience:
    A Ph.
    D.

    degree in statistical science, mathematical analysis or related fields with at least 10 years' relevant experience or a Master's degree in these fields with at least 13 years' relevant experience.


    Demonstrated exceptional ability and performance.

    To find out more about Everest Clinical Research and to review other opportunities, please visit our website at

    We thank all interested applicants, however, only those selected for an interview will be contacted.

    Everest is committed to upholding the principles of dignity, independence, integration, and equal opportunity.

    We welcome and encourage applications from people with disabilities, and upon request we will provide accommodations for candidates participating in any part of our recruitment and selection process.


    #LI-Remote
    #LI-TK1

    Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

    The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant.

    However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information.

    41 CFR c)
    #J-18808-Ljbffr


  • Insmed Incorporated Bridgewater, United States

    Company Description · Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicate ...


  • Insmed Bridgewater, United States

    Company Description · Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicate ...


  • Insmed Incorporated Bridgewater, United States

    Company Description · Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicate ...


  • Birdseye Partners Waltham, United States

    Associate Director / Director - Biostatistics · Our client is seeking a Associate Director/Director, Biostatistics to join their growing team. This person will be responsible to lead, develop, and implement statistical analyses to support the early development clinical trials, su ...


  • Editas Medicine Cambridge, United States

    At Editas, we're driven by a collective purpose, to bring transformative and life changing therapies to people living with serious diseases with the greatest unmet needs. This fuels our drive to excel in scientific innovation, allowing us to harness the power and potential of CRI ...


  • Green Key Resources Boston, United States

    Job Description · Job DescriptionThe Director, Biostatistics provides leadership and guidance for large and/or complex late phase clinical development program(s). He/she is responsible for statistical activities including: designing innovative clinical trials, authoring statistic ...


  • Biogen Cambridge, United States

    Job Description · About This Role · This is a rare opportunity to join the Biostatistics function at Biogen, an established pioneer in biotechnology The Director of Biostatistics is responsible for leading complex or integrated study design and analysis across one or my programs ...


  • Biogen Cambridge, United States

    Job Description · About This Role · This is a rare opportunity to join the Biostatistics function at Biogen, an established pioneer in biotechnology The Director of Biostatistics is responsible for leading complex or integrated study design and analysis across one or my progra ...


  • Rhythm Pharmaceuticals Boston, United States Full time

    · Company Overview · Rhythm is a global, commercial-stage biopharmaceutical company committed to transforming the lives of patients and their families living with rare neuroendocrine diseases. We develop medicines for previously untreatable or undertreated diseases and provide m ...


  • Biogen Cambridge, United States

    About This Role This is a rare opportunity to join the Biostatistics function at Biogen, an established pioneer in biotechnology The Director of Biostatistics is responsible for leading complex or integrated study design and analysis across one or m Director, Development, Clinica ...


  • Insmed Bridgewater, United States

    Company Description · Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicate ...


  • EPM Scientific Massachusetts, United States

    My Client, a Growing Biotech is Hiring a Sr Director of Biostatistics What makes this position unique? · Step into the realm of cutting-edge biopharmaceuticals, where innovation knows no bounds. My client, a renowned clinical stage Biopharmaceutical company is looking to bring o ...


  • Insmed Incorporated Bridgewater, United States

    · Company Description · Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedica ...


  • Biogen Cambridge, United States

    Job Description · Job DescriptionJob Description · About This Role · This is a rare opportunity to join the Biostatistics function at Biogen, an established pioneer in biotechnology The Director of Biostatistics is responsible for leading complex or integrated study design and a ...


  • Deciphera Pharmaceuticals Watertown, United States

    Company Description · Deciphera is a biopharmaceutical company focused on discovering, developing and commercializing important new medicines to improve the lives of people with cancer. We are leveraging our proprietary switch-control kinase inhibitor platform and deep expertise ...


  • Insmed Incorporated Bridgewater, United States Full time

    · Company Description · Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedica ...


  • Insmed Incorporated Bridgewater, United States

    Company Description: · Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicat ...


  • Moderna Theraputics Cambridge, United States

    The Role: · This role is an exciting opportunity to be a critical part of the clinical development group of a high growth organization that is radically changing the biotech industry. The Director of Biostatistics will be involved in the design, execution, analysis, and reportin ...


  • Editas Medicine Cambridge, United States

    At Editas, we're driven by a collective purpose, to bring transformative and life changing therapies to people living with serious diseases with the greatest unmet needs. This fuels our drive to excel in scientific innovation, allowing us to harness the power and potential of CRI ...


  • Everest Clinical Research Bridgewater, United States

    Everest Clinical Research ("Everest") is a full-service contract research organization (CRO) providing a broad range of expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries. We serve some of the best-known companies ...