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United BioSource Corporation.
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London, Greater London
Senior Principal Statistician
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Salary: HASH(0x55809ca02598) |
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Overview
Brief Description: Provide statistical support in the design and analysis of clinical trials, observational studies and real world evidence projects across multiple therapeutic indications, specifically oncology and rare disease. This position will also act as lead statistician, provide support for validation of tables, listings and figures, provide expert advice on at least one subfield of statistics and lead department initiatives. Leading or participating in efforts for scientific publications, manuscripts and presentations. Requirements: 8 or more years of statistical experience or relevant experience in the pharmaceutical/CRO industry Ph.D. in statistics/biostatistics with 6 years of experience (at least 4 years of clinical trials experience), or M.S. degree with at least 8 years of experience in the pharmaceutical industry Experience with application of a variety of statistical methods and ability to work on complex statistical problems Solid knowledge of SAS and familiarity with other statistical software packages Ability to clearly and effectively communicate and interact with clients Strong analytical, problem-solving, excellent written and oral communication and organizational skills Ability to work both independently and as a part of a project team Exposure and familiarity with relevant ICH and FDA guidelines Ability to search and review relevant medical literature Project management experience Specific Job Duties: Participate, without supervision, in protocol development or clinical development plan process, including discussions of study designs, selection of endpoints, sample size determination, and preparation of statistical section of the protocol Act as advisor in the conduct and analysis of clinical studies Prepare statistical analysis plans and be able to present and support them with clients or regulatory agencies Apply complex statistical methods and analyze clinical study data or observational study data including sensitivity analyses to address potential biases, handling patient switching therapies and matching strategies Provide programming and validation support Prepare statistical section of clinical trial reports or other statistical documents in support of an NDA or MAA Provide support for DMC/DSMBs both in a blinded and unblinded capacity Serve as DSMB statistician Prepare materials/presentations to support clients in regulatory related meetings at the different stages of development (IND, end-of-phase II, pre-NDA, NDA review) Participate in proposal preparation and attend business development activities by reviewing the protocol, identification of proposal specifications, develop proposal presentations as well as attend proposal bid defenses Act as Project Leader in Biometrics Project Team (Data Management, Programming, Statistics) Provide statistical support to both pre marketing (Phase I-III) and post marketing studies (i.e., REMS, Registry, Survey, Chart Review, or other post marketing studies) Functionally train junior statistical personnel Develop, maintain statistical SOPs LI-CF1 ABOUT UBC United BioSource Corporation (UBC) is a leading provider of pharmaceutical support services, partnering with life science companies to make medicine and medical products safer and more accessible. Our services support the full lifecycle of medicine and medical products, including development, commercialization, and long-term value and safety. While UBC offers employment within Patient Support, Nursing, Pharmacy and Corporate, two main focus areas for the company are Clinical Development & Research and Safety & Risk Management. Members of the Clinical Development and Research teams help evaluate study protocol, target study population, recruit physicians and patients, and collect, clean, validate and report data. As a result, sponsors are able to submit findings to regulatory authorities or make a no-go decision in a timely and clear-cut manner. Additionally, our Safety and Risk Management teams develop, deliver, and report evidence to reinforce safe and appropriate product use. Through our Patient Access services, we help patients begin therapy quickly and remain on therapy, building strong relationships with patients to ensure optimal care. You can find out more by visiting www.ubc.com