ICON is a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. We specialize in the strategic development, management and analysis of programs that support Clinical Development – from compound selection to Phase I - IV clinical studies
ICON enjoys a strong reputation for quality and is focused on staff development. We make it our mission to attract the most diverse and creative minds into the business and we continually strive to provide opportunities for our people to excel, grow and build a great career. We understand that our greatest asset is the skills and talents of our people and they are truly what set us apart.
Post : Biostatistics Manager
Job Description
This role will suit a Biostatistics manger with strong people management experience within a global clinical trial environment. Are you able to demonstrate your experience managing daily activities of biostatisticians? Providing technical development as well as driving departmental initiatives. Not losing your technical expertise as the Programming Manager as you will still have functional responsibilities. If you thrive in an environment where you provide support to senior management on the department budget management, project metrics and resourcing needs, please apply
Role
- The Biostatistics and Programming department is responsible for the statistical aspects of clinical trials including experimental design, statistical programming/analysis and reporting.
- This position manages the activities of Statisticians with an aim of meeting departmental goals.
- Manages the technical development of Statisticians and provides support and drives departmental initiatives
- The role also includes functioning at a senior technical level on projects as required.
Responsibilities
- Management of the assigned line reports with regard to providing leadership for their effective development and high quality delivery of projects
- Provide support to senior management on the department budget management, project metrics and resourcing needs
- For Statisticial technical expertise, provide input into the following areas:
- Manage the statistical input to study design, analysis and reporting
- Collaboration with medical scientists in the design of clinical studies and the development of study protocols.
- Ensuring appropriate analysis procedures are used in statistical analyses
- Study reports accurately describe statistical methods and results of analyses
- Reviewing and approving statistical analysis plans, statistical analyses and study reports
- Provides input to ICON and client clinical and regulatory departments on statistical issues relating to client regulatory submissions. Responds to statistical questions raised by regulatory agencies and assists clients with statistical aspects of regulatory agency negotiations.
- Assist staff members with the identification of out of scope work and work with Contracts and Proposals to secure additional project funding
- Prepares and approves research proposals and budgets to provide statistical consulting and to conduct statistical analyses for clients in the pharmaceutical, biotechnology, computer, and manufacturing industries. As needed, participates in proposal defense meetings and makes presentations at marketing meetings with prospective clients.
- In conjunction with colleagues in other locations, as needed
- Organises and conducts regular departmental meetings
- Represents Biostatistics at interdepartmental meetings
- Maintenance of professional currency and a position of respect within the Pharmaceutical Industry including investigation of new software and attendance at appropropriate meetings and courses.
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Requirements
- Masters degree (or local equivalent) in biostatistics, statistics, or related field (required)
- Ph.D. degree (or local equivalent) in biostatistics, statistics, or related field (desirable).
- Significant proven and progressive experience pertaining to Biostatistics with prior relevant management experience. In depth proven experience should be in statistical applications in the pharmaceutical industry.
- Awareness of a broad range of Biostatistical techniques for example generalised linear models, nonparametric methods, analysis of binary/categorical data, survival data etc.
- Proficient SAS programming skills.
- Ability to critically review data.
- Strong skills in organizing, planning, problem solving.
- Excellent verbal and written communication skills.
- Good interpersonal skills and team player. Ability to interface with all levels both internally and externally.
Additional Information:
Qualification: M.Sc/Ph.D
Reference: 044129
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Biostatistics
Location: Bangalore Chennai
End Date: 20th September, 2017
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