Hi

I am seeking 2 contractors for assigments in Canada :

Like to make the move ? the daily rates are excellent


The incumbent will assume a primary role in the management and conduct of
statistical project work and provide biostatistical consultancy for
relevant clinical trials, including design, analysis and reporting.  The
Senior Statistician will be responsible for following Good Statistical
Practice and ensuring regulatory compliance of statistical processes
assigned.  The Senior Statistician will assist in the development of
Biometry SOPs, participate in internal and external project team meetings
and liaise with the Sponsor as necessary.


Responsibilities

General

 Conduct all activities in accordance to Corporate Policy and Standard
Operating Procedures (SOPs) and assist in their maintenance
 Conduct all activities in accordance to Quality Assurance/Regulatory
guidelines
 Assist with the development of Standard Operating Procedures (SOPs),
training, marketing and other Department and company documents
 Support the Manager, Statistics in developing and promoting quality
assurance (QA) procedures within the Biometry group
 Participate in Biometry team meetings.
 Liaise with others i.e. Scientific Affairs & Communications, Project
Manager, clinical personnel to ensure adherence of all trial level
activities to the defined standards
 Maintain awareness of overall developments in the field of Biometry, as
well as assigned areas by literature review, attendance at professional
meetings, conferences and seminars
 Mentor direct reports and others within Biostatistics and Programming

Trial Preparation

 Provide biostatistical input to study design, including sample size
calculations, randomization-schema, etc.
 Write and/or review statistical statements and/or statistical sections of
the protocol, ensuring consistency, accuracy and Good Statistical Practice
 Review protocols for statistical validity
 Review and approve case report forms
 Attend Investigator Meetings, as appropriate

Trial Conduct

 Serve as Biostatistician on project teams, overseeing statistical aspects
of clinical trials
 Provide ongoing statistical advice to project team members and members of
Biostatistics and Programming
 Write/develop/review Statistical Analysis Plans for clinical trials
 Coordinate the production of tables, figures and listings for study
reports, including the supervision of other project team members where
appropriate
 Review computer programming of Biostatisticians and Statistical
Programmers where appropriate
 Perform study-specific data reviews and statistical analyses
 Write statistical reports, or statistical portion of integrated reports
 Contribute statistical expertise to final, integrated clinical trial
report
 Prepare statistical appendices for final, integrated clinical trial report
 Comply with relevant SOPs and observe project timelines
 Carry out independent QC procedures for tables, figures and listings

Scope of Decision Making/Authority

 Determine appropriate statistical design of clinical trial protocols
 Determine statistical methods used in the analysis of clinical trial data
 Review CRFs for statistical accuracy

Administration

 Attend and participate in regular Biometry meetings
 Provide the Manager, Statistics with a monthly Status Report (month end)
on project activities, including the identification of any major
risks/potential issues
 Participate in business development meetings with potential Sponsors
where appropriate
 Maintain awareness of overall developments in the field of clinical
research as well as assigned areas by literature review, attendance at
professional meetings, conferences and seminars

Contacts
 External
 Sponsors and potential Sponsors (where appropriate)
 External clinical Trial Project Manager (where appropriate)
 External Data Manager (where appropriate)

Internal
 Senior Director, Biostatistics and Programming
 Manager, Statistics
 Group Manager, Data Management
 Associate Director, Data Management
 Director, Global Data Management
 CroMedica Statistical Programmers
 CroMedica Biostatisticians/Trainees
 Clinical Trial Project Manager
 Business Development team members
 Medical Affairs/Operations team members
 Scientific Affairs & Communications team members


The above information on this description has been designed to indicate the
general nature and level of work performed by employees within this
classification.  It is not designed to contain or be interpreted as a
comprehensive inventory of all duties, responsibilities and qualifications
required of employees assigned to this job.








Key Performance Indicators (KPIs)

 Adherence to GCP, GSP, Corporate Policy, SOPs and QA metrics
 Quality and timeliness of relevant documents/reports e.g., clinical trial
protocol, SAP, statistical analysis of clinical trial data, final
integrated clinical trial report(s) and statistical appendices
 Effective team participation in providing statistical input in the
design, analysis and support of project team members on nominated
projects/clinical trials



Position Profile

Skills

 Outstanding interpersonal skills
 Excellent written and verbal communication skills
 Strong listening and feedback skills
 Above average analytical skills
 Proven & sound organisational skills
 Self directed problem solving skills

Experience and Qualifications

 Masters Degree in Statistics and 5 years experience in pharmaceutical
industry (pharma, biotech, CRO)
 Familiarity with ICH and FDA regulations
 Exposure to cross-functional project teams in a matrix management
environment (desirable)

Personal Attributes

 Results orientated
 High level of professionalism
 Positive “can do” attitude
 Flexible/adaptable and open to change
 Can work independently and within a team
 Strong analytical ability
 People motivator
 Honesty and Integrity


Please contact Natalie Fforde:

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Tel: 07769 700 222