Dear Allstaters

We are working on the following permanent roles for a global pharmaceutical
company based in Switzerland.  If you are interested in any of these and
would like to know more please contact Simon Ellis or Mick Messing on + 44
(0) 1727 817626, [log in to unmask] [log in to unmask]
All roles pay a very competitive salary and package as well as a generous
relocation package.  The company environment is very international and is
relaxed but professional.

Kind Regards
Simon

Statistician:
1. Be responsible for all statistical tasks on the assigned clinical trials,
e.g., clinical trial design/planning, analysis plan, reporting activities,
exploratory analyses and addi-tional analyses to support publications, and
statistical consultation during the run-ning phase.
2. Track clinical trial activities and milestones.
3. Ensure timeliness and adequate quality of all B&SR deliverables for the
assigned
trials.
4. Follow processes and adhere to specific standards as well as Health
Authority requirements (SOPs, NIPs, Master Analysis Plan, GCP, and
regulatory guidelines).
5. Establish and maintain sound working relationships and effective
communication within the clinical trial team and the B&SR team.
6. Participate in non-clinical project activities as needed.

Senior Statistician:
1. Be responsible for all statistical tasks on the assigned clinical trials,
and perform these tasks with a high level of independence e.g.: clinical
trial design/planning, analysis plan, reporting activities including
exploratory analyses and additional analyses to support publications, plus
statistical consultation during the running phase.
2. May be assigned to lead a small project or parts (e.g. indication) of a
project, initially under the guidance of a more experienced statistician,
but with increasing autonomy and accountability.
3. Track clinical trial/allocated project activities and milestones.
4. Ensure timeliness and adequate quality of all B&SR deliverables for the
assigned trials and project tasks.
5. Follow processes and adhere specific standards as well as Health
Authority requirements (SOPs, NIPs, Master Analysis Plan, GCP, and
regula-tory guidelines).
6. Participate in or lead non-clinical project activities as needed.
7. Establish and maintain sound working relationships and effective
communication within the Clinical Trial Team/International Clinical Team and
the B&SR team.


Expert Statistician:
1. Be the statistical leader and project manager for all B&SR deliverables
globally for
• a clinical development program, or
• a mega trial.
2. Ensure that clinical development program (or parts assigned) meets
scientific, regulatory, quality, and commercialization requirements, through
interaction with the IPT and ICT.
3. Perform matrix management of B&SR project team, and mentor staff as
required.
4. Ensure ECD-Bios, and modeling and simulation contribution is fully
integrated into the project.
5. Plan and track project level activities for B&SR, including resources.
6. Establish and maintain project standards (master analysis plan, full
development project specifications).
7. Plan and manage submission activities, like SCS, SCE, briefing books.
8. Participate in/lead non-clinical project activities.
9. Interact with Health Authorities and external consultants as appropriate.
Support and defend analyses and their interpretation at Health Authority
Meetings. Repre-sent Biostatistics at FDA Advisory Committee meetings.
10. Could take Trial Statistician responsibility as appropriate.


Senior Expert Statistician:
1. Be the independent statistical leader and project manager for all B&SR
deliverables globally for a large and technically complex clinical
development program, including supervisory functions like appraisals of
full-time team members.
2. Ensure that clinical development program meets scientific, regulatory,
quality and commercialization requirements, through interaction with the IPT
and ICT (e.g., drive CDP and TPP development from a statistical
perspective).
3. Be a scientific leader/expert within a TA, showing leadership/be the
point of reference in statistical methods, regulatory guidelines, project
strategies, clinical devel-opment planning and study design in specific
indications.
4. Perform matrix management of B&SR project team, and mentor staff as
required.
5. Ensure quality of scientific contributions, integrating input from
ECD-Biostatistics, Methodology, Modeling and Simulation and external
experts. Initiate and drive innovation by implementing novel methods and
innovative designs.
6. Plan and track project level activities for B&SR, including resources.
7. Establish and maintain project standards (master analysis plan, full
development project specifications).
8. Plan and manage submission activities, like SCS, SCE, briefing books.
9. Participate in/lead non-clinical project activities.
10. Interact with Health Authorities and external consultants as
appropriate. Support and defend analyses and their interpretation at Health
Authority Meetings. Take sig-nificant Biostatistics leadership role at FDA
Advisory Committee meetings.
11. Evaluate in licensing opportunities.

Statistical Modelling Expert

EDUCATION
PhD in a modeling-related field, or Masters Degree with several years of
experience, or equivalent degree/knowledge/expertise.

LANGUAGES
Fluent English (oral and written)

EXPERIENCE / PROFESSIONAL REQUIREMENT
Knowledge in statistical and/or PK/PD modeling, and preferably experience in
applying modeling to clinical drug development. Good data exploration
skills.
Background medical and PK/PD knowledge is a plus.
Knowledge of relevant software packages, including SAS and S-Plus.
Good communication and presentation skills.
Ability to work in teams. Innovative attitude.


Statistical Programmer:
1. Provide input as required at all meetings, discussions and activities
covering aspects of Statistical Reporting on trial level activities.
2. As required, make certain that documents and specifications are
consistent and comply with company standards by providing input into study
protocol, CRF, data structures, specifications of analysis datasets, pooled
datasets, listings, summaries, figures and tables for phase I – IV clinical
trials.
3. Program, according to specifications, analysis datasets, pooled datasets,
listings, tables, and figures for phase I-IV clinical trials and for SCS and
SCE.
4. Track clinical trial milestones for SR deliverables.
5. Maintain records for all assigned projects including archiving of trial
analysis and associated documentation.
6. Support senior members of SR and program statisticians in maintaining
efficient interfaces with internal and external customers.
7. Comply with pre-defined project / study standards and specifications.
8. Support SR colleagues in non-clinical initiatives.


Senior Statistical Programmer:
1. Lead the programming activities for a trial, early phase project,
indication, or publication activities; lead a complex/large project under
supervision of a Program Statistician / Group Head.
2. Maintain efficient interfaces with internal and external customers with
support of SR management and the Program Statistician.
3. Develop resource plans as required with support of the Group Head.
4. Develop and comply with project / study standards and specifications
following internal guidelines.
5. Make certain that documents and specifications are consistent and comply
with company standards by providing input into study protocol, CRF and data
structures tables, listings and figures for phase I-IV clinical trials and
submission activities.
6. Program, according to specifications, analysis datasets, pooled datasets,
listings, tables, and figures for phase I-IV clinical trials and for SCS and
SCE with high quality and within milestones.
7. In consultation with the statistician, develop specifications for
analysis datasets, pooled datasets, and listings.
8. Support quality control and quality audit of deliverables.
9. Maintain records for all assigned projects and archiving of trial /
project analysis and associated documentation.
10. Participate in the selection of CROs and supervise the SR trial
activities of the CROs.
11. Provide input on process improvement initiatives and participate in
non-clinical project activities.


Principal Statistical Programmer:
1. Manage the programming activities for a global project following internal
project management guidelines including resource planning.
2. Act as Program Programmer for assigned projects and take a programming
leadership role on the B&SR project team.
3. Maintain efficient interfaces with internal and external customers with
advice from SR management.
4. Develop and comply with project / study standards and specifications
following internal and regulatory guidelines.
5. Oversee programming style, quality of SR contributions and compliance
with timelines.
6. Provide SR input and lead sections of Full Development and Submission
Working Groups.
7. Ensure that documents and specifications are consistent and comply with
company standards by providing input into study protocol, CRF and data
structures.
8. Program, according to specifications, analysis datasets, pooled datasets,
listings, summaries, figures and tables for phase I-IV clinical trials and
for SCS and SCE. Ensure quality control and quality audit of deliverables.
9. Maintain records for all assigned projects and archive trial / project
analysis and associated documentation.
10. Participate in the selection of CROs, as required, and supervise SR
project activities for CROs.
11. Train staff on trial and project level activities and internal
processes.
12. Participate in or lead non-clinical project activities.



Senior Principal Statistical Programmer:
1. Act as independent Program Programmer for assigned projects, take a
programming leadership role on the B&SR project team. Act as a deputy for
Group Head on key projects.
2. Maintain efficient interfaces with internal and external customers
consulting SR management for high level strategic advice.
3. Manage complex projects.
4. Oversee programming style, quality of SR contributions and compliance
with timelines.
5. Develop and implement project / study standards and specifications for
complex projects in compliance with internal and regulatory guidelines.
6. Plan resources for key sub-areas within SR (e.g., TAs).
7. Ensure that the study protocol and CRF are consistent and comply with
company standards.
8. Program analysis datasets, pooled datasets, listings, summaries, figures
and tables for phase I-IV clinical trials and for SCS and SCE according to
specifications.
9. Participate in the selection of CROs and supervise SR activities for
CROs.
10. Keep up-to-date with state of the art programming techniques.
11. Induct, supervise (matrix) and train programmers on programming skills,
trial and project level activities, and internal processes.




Simon Ellis
Biometrics Recruitment

DDI +44 (0) 1727 817626
Fax +44 (0) 1727 844838
www.keypeople.co.uk