Senior Biostatistician (FSP)

Company: Cytel Software Corporation
Location: Cleveland
Posted on: May 26, 2023

Job Description:

At Cytel, we work hard to create successful careers with significant professional growth for our employees, as a result of which they work hard to make Cytel successful. Cytel is a place where talent, experience and integrity come together to advance the state of clinical development. Cytel''s Functional Service Provider (FSP) department offers statistical programmers, biostatisticians and clinical data specialists amazing opportunities to work on client projects.As a Senior Biostatistician you will support Cytel and a client of our Functional Service Provider (FSP) division''s Full Development activities. You should have experience with clinical trials and a solid background in statistics. Contributions may include:Participation in clinical trial activities (mostly phase 2-4) as part of a cross-function teamLead or support clinical trial activities from a statistician perspective Develop, contribute to and review Statistical Analysis Plans (SAPs) and provide specifications for the programming activitiesOversee programming activities (mostly using SAS), including hands-on programming contributions and QC of programmers'' (and other statisticians'') deliverablesContribute to project level activities (e.g. pooling specification, ISS/E planning, submission and Health Authority Questions) as appropriateSupport reporting of clinical trial activities and communication with clinical team members.Provide statistical input to clinical study protocol development as requiredReview and give input to other documents (e.g. clinical study report) as appropriateContribute to other activities, e.g. adhoc requests, publication related analyses etc. as appropriate.What we are looking for:Masters degree in statistics or a related discipline. At least 2-4 years'' experience supporting clinical trials and projects as a statistician in a pharmaceutical company or in an FSP model at a CRO Experience with regulatory submission activities, clinical summaries etc. is a plusSolid technical/methodological skillSolid experience writing Statistical Analysis Plans and overseeing TFL production from a statistical perspectiveStrong SAS skillsFamiliarity with CDISC specifications, in particular ADaM and reportingGood operational and communication skillsConstructive collaborative attitude Results-oriented with good ethicsWhats in it for you:You will have the opportunity to play an integral role helping our clients and the industry shape the future of drug developmentYou will be part of an exciting new chapter in Cytels history with high growth and opportunities to progress within the companyWork in an environment designed for an entrepreneurial minded person with a lot of energy, ideas and courage for their implementationWork with and leverage the best and brightest minds in the industryLI-CR1Cytel Inc. is an Equal Employment / Affirmative Action Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law.Cytel 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 Cytels human resources department to obtain prior written authorization before referring any candidates to Cytel. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and Cytel. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of Cytel. Cytel shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies.RequiredPreferredJob IndustriesCustomer Service

Keywords: Cytel Software Corporation, Cleveland , Senior Biostatistician (FSP), Other , Cleveland, Ohio