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