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Dear Allstat, Please find the latest PERMANENT Biostatistics vacancy. The Role Oversees statistical aspects of multiple clinical development programs and internal systems, serves as internal statistical consultant for multiple areas. Plans specialized clinical trials to establish product's superiority over other currently available products, or development areas new to the industry. Publishes technical reports and presents at external scientific meetings, serves as co-author on company-sponsored publications involving clinical trials. Represents the company in regulatory discussions involving nonstandard statistical techniques for the assigned programs. Accountabilities ¨ Leads statisticians for multiple programs. ¨ Contributes to the resolution of nonstandard statistical technical issues. ¨ Serves as statistical expert on problems associated with a particular design or analysis. ¨ Primary contact and prime spokesperson for communications with other parties for the assigned programs ¨ Communicates with regulatory agencies regarding complicated statistical issues for the assigned programs Desired Knowledge ¨ Broad clinical trial design knowledge as applied to multiple classes of drugs and different phases. ¨ Knowledge of simulation techniques to provide informed opinions on drug development. ¨ Expert level knowledge of statistical software and broad knowledge of other advanced software products, programming languages, and technologies necessary to perform very complex statistical analyses and design internal systems. ¨ In depth knowledge of multiple clinical areas and related disciplines such as Pharmacokinetics. Functional/Technical ¨ Ability to design complicated clinical development plans in diversified therapeutic areas. ¨ Ability to deign or perform complicated statistical analyses in broad statistical technical areas. ¨ Assists in assessment of the impact of study designs and clinical development plans on the development of compounds and strategic development of the company business. ¨ Ability to author and review statistical sections of IAE and IAS of NDA and other submissions. ¨ Ability to define cross-function task forces to support global regulatory submissions. ¨ Forward thinker with broad background of problem identification and resolution. ¨ Knowledge of major activities involved with regulatory submissions and ability to interface well with other clinical scientists to ensure smooth incorporation of novel statistical techniques in submissions. Approach ¨ Projects, defines and clarifies emerging needs of product teams and strategic teams and aligns Stats group's activities to meet these needs. ¨ Develops and communicates plans and processes that deliver solutions of value to product teams and strategic teams beyond expectations ¨ Ensures Stats group activities performed for business partners provide value and manages business partner expectations accordingly Working Relationships ¨ Outlines the direction, facilitates effective interactions, and generates excitement for the Stats group to excel ¨ Leverages the experience and knowledge found in the Stats group, product teams and strategic teams when developing team and project plans. Managing Change ¨ Identifies and communicates opportunities provided by changes in business environment and translates strategic changes into workable plans for the team to meet changing business needs. ¨ Prepares the team to effectively respond to and adapt to change. ¨ Act as a role model and motivates others to make changes that improve the way things are done, allowing freedom for failure. Results Orientation ¨ Develops plans and processes for Stats group to achieve priority initiatives in a time sensitive manner. ¨ Communicates results expectations to group members and holds individuals and the group accountable for achieving results. Leadership ¨ Communicates, leads by example and motivates others to demonstrate behaviors that support team and company goals. ¨ Initiates feedback process and seizes coaching opportunities to develop, train and motivate others. ¨ Identifies, promotes and tracks learning opportunities for group members, while continuously pursuing self-development and growth. Education and Experience ¨ PhD in Statistics or Biostatistics with 8+ years of experience supporting clinical trials in the pharmaceutical industry; ¨ MS in Statistics or Biostatistics with 10+ years of experience. Physical Demands ¨ Ability to drive to or fly to various meetings/sites - may include overnight stays. ¨ International travel may be required. I also have a variety of other Biometric specific vacancies available in the UK and throughout Europe. Inclusive of SAS programming, Statistical, Data Management functions, please call me for further details.... If you would to discuss this role in greater detail or your application / suitability to this or further roles, please call me or email me in confidence. If you are not available or suited to this position, please feel free to pass my details on. For a confidential consultation call Mathew Hogan on 0044 (0) 207 255 6665 or email your CV to mathew.hogan <mailto:[log in to unmask]> @1st-pharmapeople.com Mathew Hogan Senior Consultant Pharmaceutical, Biometrics & CRO Division 1st Pharma People A Division of 1st-IT People Tel: +44 (0) 207 255 6665 Fax: +44 (0) 207 255 6656 <mailto:[log in to unmask]> mailto:[log in to unmask] <http://www.1st-pharmapeople.com/> www.1st-pharmapeople.com PLEASE NOTE: As of 31st May 2005 our office address will change to; 1st IT People, 3rd Floor, Woolverstone House, 61-62 Berners Street, London. W1T 3NJ. As a result of this, we do have a new telephone number of 0207 255 6665. Please note our previous phone number will still work. 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