Novartis Pharma Are seeking various levels of clinical Statisticians and
Clinical SAS Programmers for their offices in Switzerland and USA (New
Jersey) , Please take time to View the vacancies below for:

1. Statistician 0-3 Years Clinical Trials
2. Senior Statistician 3-8 Years Clinical Trials
3. Expert Statistician - PhD Candidate with at least 5-8 years experience
4. Senior Expert Statistician , as above but would suit candidate with at
least 10+ years
5. Pk/PD Modelling and Simulation statistician
6. SAS Programmer - All Levels

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 additional 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 Novartis and project specific standards
as well as Health Authority requirements (SOPs, NIPs, Master Analysis Plan,
GCP, and regula-tory 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 to Novartis and project 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, regu-latory, 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 refer-ence 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 inno-vation 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.

CONTACT NATALIE AT FFORDE FOR FURTHER INFORMATION:

Natalie Fforde
Managing Director
Fforde
Curtis House
34 Third Ave
Hove
BN3 2PD

Tel: 01273 722366
Fax: 01273 325350
Mobile: 07769 700 222
Email: [log in to unmask]

www.fforde-management.com