SENIOR STATISTICIAN CLINICAL PHARMACOLOGY
Work Location:
Functional Area:
Job Type:
Basel, Switzerland
Oncology
Full Time
Novartis provides healthcare solutions that address the evolving needs of patients and societies
products to prevent and treat diseases, ease suffering and enhance quality of life.
Novartis research is driven by a distinctive clinical and scientific strategy focusing on unmet
medical need and knowledge of disease
Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 121,000
associates and operate in more than 140 countries around the world.
Job Description:
The Senior CP Statistician is responsible for all Clinical Pharmacology related statistical tasks of
individual clinical trials. He/she takes on project level tasks as a member of the International
Clinical Team, initially under the supervision of a more experienced CP Statistician or the Group
Head but with increasing autonomy and accountability.
Major Activities
1. Be responsible for all statistical tasks of the assigned CP trials and of the Pharmacokinetics (PK)
parts in the assigned Clinical Research trials, and perform these tasks with a high level of
independence. This includes clinical trial design/planning, analysis plan, reporting activities
including exploratory analyses of PK/PD relation-ships and additional analyses to support modeling
activities and publications, plus statistical consultation during the running phase.
2. Be assigned to lead a project or parts of it as a member of the International Clinical Team,
initially under the guidance of a more experienced CP 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 CP 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, BGs, Master Analysis Plan, GCP, and regulatory 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
Potential additional assignments depending on experience:
1. Ensure that the Clinical Pharmacology parts of the clinical development program meet scientific,
regulatory and quality requirements, through global interaction with the Project Team, CP and the
modeling groups.
2. Recognize and implement opportunities for innovative designs, PK/PD exploration, novel
analyses and modeling and simulation in CP and non-CP studies.
3. Coordinate with CP, PK and modeling groups to ensure adequate modeling and simulation
contributions, including PK/PD modeling, for the projects assigned.
Minimum Requirements:
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At least Masters Degree in Statistics (or equivalent degree) with 5 years of experience or
PhD with 2-3 years of experience.
Fluent English Experience in all tasks of a Trial Statistician.
Proven knowledge in Statistics and its applications to clinical trials. Proven knowledge of
drug development and HA guidelines.
Background medical knowledge, preferably in relation to the specific therapeutic area.
Proven knowledge of statistical software packages.
Good communication and presentation skills.
Candidates wishing to apply should go visit our site, http://www.novartis.com/careers, and apply
for the position 127982BR