pharmalex_job_career



We are growing, grow with us!
Are you looking for a dynamic company with daily new challenges and opportunities?
Then, Pharmalex is your career opportunity. Pharmalex is one of the leading service companies for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, of the market development and any action of effective product maintenance.

 

Manager, Statistical Services

Key Responsibilities and Activities

  • Contributes to the design, statistical analysis and modelling, including Bayesian and frequentist models, simulation, designs to ensure both effective decision and submissio
  • Develops and executes statistical analysis in collaboration with the scientific programmer and the sponsor representative, as appropriate
  • Execute statistical analysis in collaboration with the scientific programmers

GxP Projects
  • Ensures that the attributed study phases are performed in accordance with the regulatory requirements, protocol, statistical/pharmacometric analysis plan and statistical methodologies and standards for the realization of the analysis
  • Produce, qualify and review the Statistical Analysis Plan, the code developed to generate the randomization list, the statistical programs, any methodology/deliverables/results/outputs/reports and amendment
  • Ensures that peer review or appropriate QC/validation is performed

Non-Clinical Projects
  • Contribute to statistics and programming applied to pharmaceutical development for process and assay development, including Quality by Design and Design Space methodologies.
  • Provide statistical support in the area of analytical laboratories
  • Contribute to the analyses of formulation, validation, and stability studies
  • Be involved in Design of Experiment approaches for method and process development, including design optimization
  • Preparation of statistical analysis plans, modeling and simulation plans
  • Develop methodologies for biomarker analysis
  • Conducting statistical analyses and performing Quality Control
  • Interpretation of analyses and writing of reports
  • Contribution to software development

Clinical Projects
  • Contribute to simulations studies for adaptive and Bayesian designs
  • Contribute to Protocol and, Statistical/Pharmacometric Analysis Plan writing
  • Contribute to statistical analysis of study data including Table Figure Listings production and review
  • Contribute to Clinical Study Report of early phase studies

Required Education and Experience
  • Master’s or PhD Degree in Statistics and 3-5 years’ experience; or equivalent combination of education and experience.
  • Some experience with SAS and R. JAGS is a plus
  • Knowledge in Bayesian statistics is required
  • Minimum knowledge of basic of IT
  • Autonomous, concentrated and high-quality work
  • Ability to work well in a collaborative team
  • High level of ownership of core responsibilities
  • Project management skills
  • Excellent customer service skills
  • Ability to adapt under regularly changing conditions
  • Dependability according to expectations
  • Very good command of English, written and verbal
  • Outstanding organization, analytical, and complex problem-solving skills
  • Excellent written, verbal and presentation communication skills
  • Language German English English
 

If you are interested in joining our Pharmalex team taking over this challenging job opportunity in our future-oriented company, we are looking forward to receive your application documents stating your earliest possible starting date, any visa requirements and salary expectations on-line.

For further information please don’t hesitate to contact us:

Mr Greg Emmerth

e-mail: greg.emmerth@pharmalex.com
Agencies only by prior agreement for the specific job opportunity.