Location: Germany (Bad Hamburg), UK (Erl Wood), France (Paris).
1 year contract (can be extended)
Best candidate will drive the decision.
As a Project Statistician the contractor will lead and provide oversight in the development of study protocols and data analysis plans in collaboration with physicians, and/or medical colleagues. The Project Statistician will be responsible for working with research associates and scientists to oversee the establishment of a reporting database and the analyses of study data. Furthermore, the Project Statistician will lead the study team on their interpretation of results and will be co-author for internal or external publication of the results.
The job tasks listed below outline the scope of the position:
Statistical Study Design and Analysis (Mainly Phase III-IIIb-IV clinical trials or observational studies)
• Operates in collaboration with study personnel to provide input on study protocol and design of studies. Writes statistical parts of protocols for clinical trials and/or observational studies.
• Assists in or is accountable for selecting statistical methods for data analysis,
• Coordinates the statistical programming with CRO statisticians and communicates accordingly with the CRO. Checks the quality of statistical output delivered by the CRO.
• Collaborates with data management in the planning and implementation of data quality assurance plans.
• Maintains currency with respect to statistical methodology, to maintain proficiency in applying new and varied methods, and is competent in justifying methods selected.
• Participates in peer-reviewing work products from other statistical colleagues.
• Supports medical affairs in the statistical aspects of designing, implementation and results interpretation of patient support programs.
Communication of Results and Inferences
• Collaborates with team members to write reports and communicate results.
• Assists with or is responsible for communicating study results via regulatory submissions, manuscripts, or oral presentations in group settings, as well as for communicating one-on-one with key customers and presenting at scientific meetings.
• Responds to regulatory or reimbursement queries and interacts with regulators or payers.
Therapeutic Area Knowledge
• Understands neurosciences disease states, specifically experience working in depression, schizophrenia, ADHD and/or Alzheimer, in order to enhance the level of customer focus and collaboration and is seen as a strong scientific contributor.
• Ability to connect internally and externally with relevant players in the therapeutic area and to be a key contributor in relevant strategic meetings
Regulatory Compliance
• Performs work in full compliance with assigned curriculum(s) and will be responsible for following applicable Corporate, Medical, local, and departmental policies, procedures, processes, and training.
Minimum Qualification Requirements:
• M.S., Ph.D., or equivalent experience
• Statistics, Biostatistics, or equivalent of field study
• Minimum 5 years experience in similar job
Other Information/Additional Preferences:
• Leadership and teamwork skills
• Strong interpersonal communication skills for effective customer consultation
• Self-management skills with a focus on results for timely and accurate completion of competing deliverables
• Creativity and innovation
• Demonstrated problem solving ability and strategic thinking
• Resource management skills
• Business process expertise associated with critical activities
• Knowledge of the SAS programming language
Contactar: Pepa Polavieja (Team Leader Biomedicines, EU Biometrics, Lilly S.A).
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