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Biostatistics & Data Management Director

GSK
Job LocationWeybridge
EducationNot Mentioned
SalaryCompetitive salary
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent, full-time

Job Description

Site Name: USA - New Jersey - Warren, UK - Surrey - WeybridgePosted Date: Jul 21 2020Are you an experienced senior clinical statistician with excellent leadership skills Are you looking for an opportunity to lead data management and statistical activities as well as managing a team of experts If so, this could be a great opportunity to explore!As the Biostatistics & Data Management Director, you will deliver medical/scientific excellence and dynamic leadership of data management and statistical activities on preclinical and clinical studies, health outcomes and other clinical evidence gathering activities conducted by GSK Consumer Healthcare.You will lead and manage a team of experts in data management, data programming, biostatistics by providing technical/scientific expertise and dynamic leadership on best operational and leadership practices. You will be interacting with internal teams such as Category, Category Medical, Regional Medical, Clinical Development and GSK Pharma teams, as well as external groups and individuals, such as Investigational Sites, Contract Research Organizations, Health Care Practitioners, Government agencies, Health Care Organizations to help achieve company objectives and to build GSK reputation.In addition, you will have significant accountability for- and oversight of the following activities with the complexity of multiple stakeholders, different Regions and LOCs with complex governance and business expectations:

  • Represent and/or provide oversight for GSKCH interactions with regulators for Statistical and Data Integrity issues
  • Provide governance for all rightsourcing activities related to BDM
  • Adopt and implement the latest statistical and analytical techniques to maximise the value from new and existing clinical evidence sources
  • Key point of contact/SME for x-division, x-company initiatives related to BDM / Clinical Development
  • Expert data management and statistical input to category project teams on strategy and targeted clinical development plans and the clinical studies integrated therein which deliver robust regulatory submissions and impactful products claims in support of successful product launches
  • From a data management and statistical perspective, the design, conduct, analysis, interpretation, disclosure, publication and oversight of clinical / human subject research study protocols and reports to ensure that they are scientifically robust from a data integrity and statistical standpoint
  • Subject matter expertise on implementing BDM best practice in line with ICH GCP and/or internal policies together with evolving trends in data management and statistics: leading to GSK CH R&D improvement and change implementation
  • Developing and deploying the BDM operation processes working for the conduct of human subject research globally, not just those projects initiated by the Category Medical Teams
    • These activities will involve building extensive networks and working closely with business leaders and other stakeholders.This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
  • Overall responsibility for management of GSK employee data managers and statisticians. This includes effective resource management to balance workloads and assigning projects appropriately based requirements and skills/abilities of staff members. It also includes project assignments to contract data managers, programs and statisticians who are not directly managed by GSK.
  • - Includes coordination and oversight of any strategic contract or out-sourcing services supporting delivery of BDM goals in supporting GSKCH business deliverables
  • Ensuring appropriate review and approval of relevant study documents in line with Medical Ways of Working and BDM operating procedures including but not limited to Protocols/Outlines, Statistical Analysis Plans (SAPs), study reports and other documents, providing specific comments and guidance.
  • - Includes supporting the development of innovative study designs and associated analytical methods for looking a clinical study data and other forms of clinical evidence including Real World Evidence.
  • Provide a higher level of process and technical expertise to guide BDM staff when difficult challenges arise in clinical studies; liaise with other departments and/or outside experts in those situations.
  • Directly support BDM delivery team on the more demanding projects, including submission projects; act as backup for study statistician in cases of absence, or need for escalation/troubleshooting.
  • High level account management responsibilities for one or more categories or special projects;
  • High level departmental administrative responsibilities, including process improvement – Document, review and manage BDM related processes; provide and oversee training requirements in those processes to current and new employees.
  • Responsible for performance of BDM team managed, including meeting timelines, ensuring quality of work including development and measuring performance metrics.
  • Responsible for overall BDM strategy for existing and future software applications, in particular in relation to study conduct and reporting across all categories and regulatory classifications
  • Responsible for identifying, recruiting and maintaining key talent within the BDM team
  • - Establishing a culture of development and reward
  • - Creating an environment of creativity, flexibility and enterprise thinking
  • Represent GSKCH at external meetings to raise the profile of BDM
    • APPLICATION CLOSING DATE – 23rd August 2020Please take a copy of the Job Description, as this will not be available post closure of the advert.When applying for this role, please use the ‘cover letter’ of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application. Why you Basic Qualifications: We are looking for professionals with these required skills to achieve our goals:
  • Masters level degree in Statistics or related field (or equivalent)
  • Significant experience as a clinical statistician, with progressive responsibilities towards leadership, people management and high-level statistical contributions, such as submission work.Excels in all the skills and abilities required of statisticians (at

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