www.acad.jobs : academic jobs worldwide – and the best jobs in industry
                
     
Position: Director, Biostatistics - Epidiolex
Institution: GW Pharmaceuticals plc.
Location: United Kingdom, United States
Duties: Lead drug development project(s) by developing and executing statistical strategy, design, and analyses for clinical trials; Manage biostatisticians within the drug development project(s); Manage CROs providing statistical support to ensure timely delivery of quality analysis results; oversee contracts and invoices; Approve guidelines and standards of CROs to ensure quality of deliverables; Contribute to or lead Biometrics teams to develop, implement, and maintain department standards and practices; Provide technical support and input to project statisticians and statistical tasks; Provide statistical expertise to prepare for meetings with regulatory agencies; attend meetings with regulatory agencies; respond to statistical questions from regulatory agencies and support and defend clinical programs
Requirements: PhD or MS degree in statistics, mathematics, or a related discipline with a statistical focus; A minimum of 8 years of experience; supervisory experience is preferred; Expert knowledge of clinical trial design and analysis, including experience with complex statistical methods and models, including statistical principles and methodology and principles of statistical inference, including hypothesis testing and deriving estimates, parametric and non-parametric models and techniques, principles of sample size calculations for comparing two arms, principles of design of experiments in introducing conditions designed to affect an outcome of interest, and phase II-IV clinical trial data analysis; Experience in using SAS or R; knowledge of other statistical applications and programming languages a plus
   
Text: Skip to main content Director, Biostatistics - Epidiolex US - Field Based - Various UK - Field Based - Cambridge Apply About Greenwich Biosciences: Greenwich Biosciences and GW Pharmaceuticals recently became part of Jazz Pharmaceuticals, creating more opportunities to serve patients and grow employees' careers. As an innovative global biopharmaceutical leader, our purpose is to innovate to transform the lives of patients and their families. We focus on patients with high unmet needs and pursue innovative and differentiated therapies that establish new or better standards of care in neurosciences and oncology. About the role: The Director, Biostatistics is the statistical lead on one or more Jazz Pharmaceuticals drug development projects and will act as a statistical expert across all studies in the project(s). This position can have direct reports up to Associate Director level, participates in regulatory interactions for the project(s), provides statistical leadership for direct reports, and ensures the quality and timeliness of biostatistics analyses. Contributes to or leads development of departmental processes and procedures, including establishing standards and operating procedures. Lead statistical input and strategy in governance team discussions. This position works collaboratively with clinicians, data managers, other biostatisticians, and statistical programmers in the planning, conduct, and analysis of clinical studies in all phases, including integrated reporting. Oversees professional development of biostatisticians. Responsibilities: Lead drug development project(s) by developing and executing statistical strategy, design, and analyses for clinical trials. Manage biostatisticians within the drug development project(s). Manage CROs providing statistical support to ensure timely delivery of quality analysis results; oversee contracts and invoices. Approve guidelines and standards of CROs to ensure quality of deliverables. Contribute to or lead Biometrics teams to develop, implement, and maintain department standards and practices. Provide technical support and input to project statisticians and statistical tasks. Provide statistical expertise to prepare for meetings with regulatory agencies; attend meetings with regulatory agencies; respond to statistical questions from regulatory agencies and support and defend clinical programs. Collaborate with researchers and thought leaders in the planning of clinical development programs and the publication of study data. Present study results to internal and external audiences. Develop statistical programs as necessary to simulate clinical trial design operating characteristics, simulate clinical trial design operating characteristics, perform analysis, prepare data displays, and verify the correctness of data and analyses. Be able to conduct independent research and resolve statistical methodological issues. Recruit, develop, and supervise internal and external statisticians to achieve project goals. May lead outsourcing statistical activities within a program. Required Experience: Expert knowledge of clinical trial design and analysis, including experience with complex statistical methods and models, including statistical principles and methodology and principles of statistical inference, including hypothesis testing and deriving estimates, parametric and non-parametric models and techniques, principles of sample size calculations for comparing two arms, principles of design of experiments in introducing conditions designed to affect an outcome of interest, and phase II-IV clinical trial data analysis. Experience in using SAS or R; knowledge of other statistical applications and programming languages a plus. Expert knowledge of applicable regulatory requirements and guidelines, e.g., ICH Guidelines and drug development regulatory requirements as they relate to statistics, including statistical contributions to marketing applications and CDISC SDTM and ADaM standards. Able to work in a fast-paced, flexible, team-oriented environment. Possess excellent interpersonal and communication skills (written and verbal). Strong attention to detail with a view to bring studies to a quality conclusion. Flexible, positive, creative thinker, good communicator. Work without close supervision. Well-developed time management skills are important. PhD or MS degree in statistics, mathematics, or a related discipline with a statistical focus. A minimum of 8 years of experience; supervisory experience is preferred. Expert knowledge of drug development regulations pertinent to statistical analysis. Knowledge of the neuroscience therapeutic area is preferred. Bayesian and adaptive design experience. Experience in contributing to NDA or BLA submissions and defense is required. Proficient SAS programming skills, solid understanding of CDISC models and standards. Excellent writing and communication skills, demonstrated leadership abilities and excellent interpersonal skills. GW's VISION: Unlock the potential of cannabinoid science to transform the lives of the patients and their families GW's MISSION: Lead the world in developing and commercialising regulatory approved cannabinoid medicines, putting patients first Our efforts are guided by several fundamental values. At all times we strive to be: Patient Driven - We never forget who we're striving for Passionate - We are here to change lives Innovative - We challenge ourselves to find new and better approaches Collaborative - We accomplish more through working together and valuing one another Accountable - We take responsibility and deliver on our commitments Integrity - We are fair, honest, and ethical Excellence - We pursue the highest standards for ourselves and for our industry Join Us! Important notice to Employment businesses/ Agencies GW Pharmaceuticals (“GW”) does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GW’s Talent Acquisition department to obtain prior written authorisation before referring any candidates to GW. The obtaining of prior written authorisation is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GW. In the absence of such written authorisation being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GW. GW shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Apply Posted 6 Days Ago Full time R0002421 About Us As an innovative global biopharmaceutical leader, our purpose is to innovate to transform the lives of patients and their families. We focus on patients with high unmet needs and pursue innovative and differentiated therapies that establish new or better standards of care in neurosciences and oncology. Follow Us © 2021 Workday, Inc. All rights reserved.
Please click here, if the job didn't load correctly.







Please wait. You are being redirected to the job in 3 seconds.