Dear Allstat,

		Please find below the latest permanent vacancy based in the UK

		Biostatistics Manager

		Objectives

		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
		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.


		The following are examples of technical and behavioural competencies that are required to achieve the objectives of this position.

		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.
		Strategic 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.
*	Builds and maintains networks with people across Takeda and gains support of stakeholders within Takeda as needed to achieve plan goals.
*	Openly shares information with Stats group and those outside the group who are impacted by the information, and encourages others to do the same.
		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.
*	Plans for and secures needed resources for the group to effectively meet its goals. 
*	Makes decisions and assists others in making decisions that support function and broader company goals.
		Leadership

*	Communicates, leads by example and motivates others to demonstrate behaviours 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.

		Scope:

		Associate Director of Statistics provides assignments, coaching and high-level technical and strategic consultation. Work is performed without technical direction. Self motivates to understand the goals of the development programs in order to provide top level internal consultation on statistical issues. Recommends strategic development directions for the assigned programs. Often self-initiates assignments within the assigned programs. Usually self-supervisory. 

		Education and Experience
		PhD in Statistics or Biostatistics with 8+ years of experience supporting clinical trials in the pharmaceutical industry or MS in Statistics or Biostatistics with 10+ years of experience.

If you would like further information on this opportunity please call or email me for a confidential conversation.

Kind regards,

Robert Whyte
Consultant ~ Clinical & Biometrics Division
James Harvard Pharmaceutical Ltd

T. 020 7922 7117   M. 07957 190569     F. 020 7922 7101
E: [log in to unmask]    
W: www.jamesharvardpharma.com

25 - 27 Wootton Street : Waterloo : London : SE1 8TG

We are exhibiting at the 2006 annual PSI conference Stand 3 from 15-17 May 2006. 

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