A privately held pharma-company is advertising a vacancy for a Senior Statistician, based in their office in Switzerland.
The company is active in the life sciences areas of drug development, GMP manufacturing of proprietary drugs, diagnostic tools, and investment management, and focuses on innovative treatments, such as in oncology with a focus on solid tumours, as part of their business.
This is an exciting opportunity to work with a leading pharmaceutical organization and support their R&D operations to create new, viable treatments.
Job Responsibilities :
Provide statistical input to the design, analysis and interpretation of clinical studies.
Author statistical sections of protocols and statistical analysis plans.
Ensure provision of quality and timely statistical analyses results that support quality and timely decision making.
Lead statistical and programming study teams and perform statistical analyses.
Coordinate and provide statistical oversight for outsourced studies, ensuring CROs accountability for the quality of their deliverables.
Represent statistics within cross functional study teams and provide statistical support and solutions.
Assist with in interactions with health Authorities.
Maintain current scientific and regulatory knowledge.
Provide input / lead internal process improvement.
Ensure adherence to GCP, regulatory guidelines, standard processes and SOPs.
Skills and Requirements :
or PhD in Mathematical or related field.
Minimum of 4 years' experience as project / study statistician in Clinical Development in the pharmaceutical industry or CRO.
Strong statistical methodology knowledge and applications. Experience using Bayesian designs is a plus.
Excellent programming skill in SAS. Experience using R is a plus.
Good experience using CDISC standards.
Demonstrated project management skills.
Demonstrable multitasking, project management, and execution skills.
Good interpersonal skills, including communication, presentation, persuasion, and influence.
Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
Proficiency with computer skills, such as MS Office.