Job Title: Biostatistics Manager
Ref no: 34545
Position: Permanent
Location: Switzerland
Responsibilities:
Management
• Recruit, manage and provide technical input to statistical staff
supporting clinical research.
• Oversee contract research organizations on deliverables if work is
outsourced.
Functional Knowledge
• Provide statistical expertise input into early development clinical
development plans.
• Provide statistical design and analysis expertise for planning,
analyzing and reporting clinical pharmacology trials (e.g. first evaluation
in humans, bioequivalence, drug-drug interaction studies) in volunteers as
well as in all therapeutic areas towards the clinical development of new
drug candidates from first in human lead molecule stage to proof of concept
full development stage.
• Responsibilities include providing statistical expertise to
protocol development, statistical analysis plans, conduct of statistical
analyses and contributing to final joint pharmacology and statistical
reports.
• Provide integrated data summaries of pharmacokinetics and
pharmacodynamics results in clinical pharmacology summary report for
regulatory submissions.
Leadership
• Promote, educate and mentor direct reports, clinical statisticians,
as well as to clinical pharmacology scientists in the design and analysis
of clinical pharmacology studies by sharing best practices and experiences,
providing consultancy and technical input.
Problem Solving
• Develop, implement and communicate practical and statistically
sound solutions, methods and processes in order to better support drug
development in the future. Coordinate external collaborations supporting
the development of these new methods as applicable.
Nature and Area of Impact
• Influence efficient drug development projects and strategies by
providing statistical expertise in clinical pharmacology development.
• Contribute to regulatory interactions and submissions as well as to
publications
Interpersonal Skills
• Work effectively across both statistical and pharmacology
disciplines facilitating discussion on issues across disciplines and across
therapeutic areas.
• Interact with clinical and project teams to provide statistical
input into drug development through technical expertise
• Communicate technical details effectively between scientists,
clinicians and statistical colleagues
If interested please email or phone me.
Kind regards
Reshma
Reshma Nanjappa
Pharma Consultant
Square One Resources Ltd
Earl Place
15 Appold Street
London, EC2A 2AD
Tel: +44 (0)20 7208 2848
Fax: +44 (0)20 7208 2858
Mob: +44 (0)7834 131520
Email: [log in to unmask]
Web: www.squareonepharma.com
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