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Senior Biostatistician SAS Statistical Analysis

Company name
Smith & Nephew.

Location
Andover, MA

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Description ABOUT US Smith & Nephew supports healthcare professionals in\u00a0more than 100 countriesin their daily efforts to improve the lives of their patients. We do this by taking a\u00a0pioneering approachto the design of our\u00a0advanced medical products and services, by securing wider access to our diverse technologies for more customers globally, and by enabling better outcomes for patients and healthcare systems. We have leadership positions in: Orthopaedics Reconstruction - joint replacement systems for knees, hips and shoulders Advanced Wound Management - wound care treatment and prevention products used to treat hard-to-heal wounds Sports Medicine - minimally invasive surgery of the joint Trauma & Extremities - products that help repair broken bones We have around\u00a015,000 employeesaround the world. Annual sales in 2016 were more than $4.6 billion. We are a constituent of the UK's FTSE100 and our shares are\u00a0traded on the London Stock Exchangeand through\u00a0American Depository Receipts on the New York Stock Exchange(LSE: SN, NYSE: SNN) SUMMARY The Senior Statistician will be responsible for all aspects of statistical project support to clinical studies and volunteer trials and will independently and proactively ensure project statistical support needs are fully met and study designs and analyses are statistically valid and meet the recognized international standards. The jobholder will expertly and independently: provide consultancy advice on study design, write protocol statistical considerations sections and report and disseminate study results. The key focus of this position is to provide expert and timely study design and analysis consultancy across a broad range of applications, to establish full project involvement and influence, and to further develop statistical and software applications skills. The successful candidate will be responsible for all aspects of statistical project support to clinical studies and volunteer trials and will independently and proactively ensure project statistical support needs are fully met and study designs and analyses are statistically valid and meet the recognized international standards. The job holder is a senior statistician, with design and analysis consultancy skills in both clinical and research applications. The jobholder will expertly and independently: provide consultancy advice on study design, write protocol statistical considerations sections and report and disseminate study results. The key challenges of the position are to provide expert and timely study design and analysis consultancy across a broad range of applications, to establish full project involvement and influence, and to further develop statistical and software applications skills. \u00a0Essential Job Functions Lead project statistical support ensuring that needs are fully met by expert and timely statistical consultancy and support. Input into clinical research programmes and study protocols. Independently provide study design consultancy, decide on statistical analysis methodology, specifying the protocol statistical considerations section including the analysis plan. Review statistical considerations sections, results sheets and clinical study reports. Collaborate on research and development projects advising on study design, analyzing and reporting results. Specify table templates, write analysis dataset specifications, analyze data, write clinical study reports, results sheets and data on file reports, disseminate study results with study teams and brand managers, write manuscript results sections for publication and critique competitor promotional material. Develop, test and run SAS programs for analysis datasets, report tables, graphics and statistical analysis, liaising with statistical programmers as appropriate. Deliver training and awareness sessions to research and clinical research staff at all levels. Apply high standards of occupational Health & Safety in the workplace to comply with company policy and procedures. Identify and lead systems and process development to improve the efficiency and quality of work within the statistics function under the management of the Statistics Manager Further develop knowledge of design consultancy and analysis methodology, and statistical software packages (e.g. SAS and Proc Statxact, MlwiN, Nquery, PEST, EAST, Quality Analyst). Validate software, in the role of system owner or tester, and test SAS Macros, maintaining the required validation and testing documentation. To perform all activities in compliance with relevant GCP, GMP and Quality Systems standards and specifically with FDA Quality System Regulation (including 21CFR Part 11), EN46000 and ISO 13485. Lead development and maintenance of in-house programming standards in line with the above quality standards and regulations. To ensure full commercial value is realized from the clinical trial evidence through promotional material and publications in liaison with the CRAs\/CPMs and commercial Qualifications Requirements The job holder is a professional statistician (including a Statistics BSc\/ MSc \/ PhD), with design and analysis consultancy skills and knowledge across a broad range of applications. Statistician qualifications required (including a Statistics BSc\/ MSc \/ PhD or equivalent), with design and analysis consultancy skills and knowledge across a broad range of applications. Provides expert statistical analysis consultancy to internal customers The role requires developing strong relationships with internal members of clinical sciences (in particular other members of statistics and data management and clinical). The role also necessitates building working relationships with project teams in other areas of the business in relation to delivering clinical evidence to the business required for needs for NPD decision making, product registration and commercialization product support. Ability to deliver clinical evidence (clinical study reports, results sheets) according to agreed deadlines Desire to improve knowledge in, and keeping up with advances in, statistics relating to clinical trials (and in wider areas) and leading procedural changes where necessary.

Company info

Smith & Nephew.
Website : http://www.smith-nephew.com

Company Profile
The Group has a history dating back 160 years to the family enterprise of Thomas James Smith who opened a small pharmacy in Hull, England in 1856. On his death in 1896, his nephew Horatio Nelson Smith took over the management of the business.A few days after the declaration of World War 1 in 1914, Horatio Nelson Smith (the nephew of the company founder T. J Smith) met with an envoy of the French President in London. The company was awarded a contract to supply £350,000 of surgical and field dressings, to be delivered in five months. By the late 1990s, Smith & Nephew had expanded into being a diverse healthcare conglomerate with operations across the globe, including various medical devices, personal care products and traditional and pioneering woundcare treatments. In 1998, Smith & Nephew announced a major restructuring to focus management attention and investment on three business units — wound management, endoscopy and orthopaedics— which offered high growth and margin opportunities.

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