Position:             Statistical Manager with experience in Clinical
Pharmacology

Company:           Global Bio/pharma

Location:            Confidential (Continental Europe/Central location)

Remuneration:     Market leading package and full benefits

Relocation:         Full international relocation assistance

 

 

AspirionPharma have now been retained by our client to search on a new
position within the biostatistics and statistical programming area.

 

This is an exciting role reporting into the World wide Director of
Biostatistics and Statistical Programming and will support the Clinical
Research department in Clinical Development.  The main objective will be
statistical support for Phase I clinical pharmacology trials to enhance
clinical development.

 

The company is a leading, innovative organisation committed to pushing
forwards boundaries in scientific excellence.

 

Our search to find the right candidate is global in nature and we will
accept contact from candidates based in any country - as long as have
the necessary experience, ambition and ability.

 

Internally: 

PK/PD Scientists, Discovery Scientists, Biostatisticians, Statistical
Programmers/Analysts, Application Developers, Clinical Development
Personnel, Regulatory Affairs Personnel, Clinical Teams, Project Teams,
Global Product Development Personnel

 

 

Externally:

External experts in statistics, Key Opinion Leaders in stats and
clinical pharmacology, regulatory agencies and CROs.

 

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.

 

EDUCATION/PROFESSIONAL EXPERIENCE

PhD or MS in Biostatistics/Statistics with direct experience in clinical
pharmacology

Prior management experience and at least 5 years experience in the
industry

 

LANGUAGES

The language of business at our client is English - other European
languages would be welcome but they are not a requirement.

 

SKILLS & COMPETENCIES

Strong problem solving skills and ability to analyze complex problems 

 

Proficient in SAS statistical procedures. 

 

Communicate technical details effectively between scientists, clinicians
and statistical colleagues

If you feel that this is a position which might be of interest, then in
the first instance please forward us a copy of your most recent CV.

 

Ash Butt LL.B Law (Hons) | Managing Director | AspirionPharma 

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