Biostatistics Manager
Ref: 00289
There are fantastic openings for experienced post graduate statisticians who
have worked on clinical trials in the biopharmaceutical industry to take key
managerial roles in a leading global biotechnology company. This company
that uses the power of scientific discovery and innovation in medicine to
develop novel products that that bring health improvements to people all over
the world, has 3 vacancies for Biostatistics Managers at their office in San
Francisco
JOB ROLE – Principal Responsibilities include:
• Creating statistical text for study concept documents and
protocols.
• Reviewing and approving randomization specifications.
• Creating statistical analysis plans.
• Creating templates for tables, listings and graphs.
• Reviewing and approving dataset specifications.
• Reviewing and approving key study-related documents produced
by other functions.
• Writing, testing, validating and executing software programs to
produce SDF datasets and tables, listings and graphs for inclusion within CSRs,
ISS / ISE, publications and other communications.
• Creating statistical reports.
• Creating statistical text for CSRs, clinical publications and other
communications.
• Planning and executing statistical review and QC of CSRs, clinical
publications and other communications.
• Creating RFPs from outsourcing vendors for statistical services.
• Participating in study and systems audits by CQA and external
bodies.
• May manage and develop a small number of statistical staff.
QUALIFICATIONS & EXPERIENCE:
• MS/MSc or PhD in Statistics or other subject with high statistical
content.
• 4-6 years Scientific career experience without a PhD
• 0-4 years Scientific career experience with a PhD
KNOWLEDGE & EXPERIENCE in the following:
• Statistical Methodology and Applications within Drug Development
• Drug Development Process & Operations
• The use of Biostatistical Software within Drug Development
• Clinical Trials within Pharmaceutical/Biotechnology/Public Health
setting in Industry, Government or Academia
• Drug Development (Pre-clinical Development, Clinical Development,
Medical Affairs)
• Project Planning and Management
• Communication of statistical information (written and oral)
• Development of policies and SOPs
BENEFITS OF THE ROLE: Our client offers an outstanding work environment
with a value system which ensures that every person has the opportunity to
make a significant difference. They are offering a competitive salary and
excellent career development opportunities as part of a Total Rewards
package with very competitive benefits including performance based bonus,
long term incentive program, comprehensive healthcare, illness and disability
benefits, life insurance, retirement and savings plan, employee stock purchase
plan and numerous fun social activities.
Fforde is a uniquely specialised recruitment agency/business for the
pharmaceutical, clinical research and biotechnology sectors. For applications
please email your CV to: [log in to unmask] or speak to our
specialist consultant, Den Lowpetch on 212 520 8303 who will be pleased to
give you further information and advice on your personal career needs. Visit
our website and see all our job opportunities at www.fforde-management.com
KEY WORDS: Biostatistics Manager, Statistics, Statistical Analysis, SAPs,
Statistical Reports, Staff Management, PhD, MS, MSc, Scientific, Statistical
Methodology, Drug Development, Clinical Trials, Project Planning, Project
Management, Pharmaceutical, Biotechnology
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