Principal Statistician

Ipsen•Paris, TX

53d•Hybrid

About The Position

The Principal Statistician is the lead for the statistical strategy of one or more projects/studies in Ipsen development portfolio. He/She is responsible for the discussion and implementation of rigorous, informative and when appropriate, innovative study designs, statistical models, and analysis methodologies that optimally address the research objectives by establishing the efficacy and safety of the compound. He/She is responsible for designing, implementing and reporting in a quality, timely and accurate manner, the statistical processes in clinical trials, applying state of the art concepts and tools to the interpretation of clinical trial data so that the evaluation of such data will withstand interrogation and examination by Regulatory bodies. He/She oversees external vendors for outsourced activities and is responsible for the corresponding deliverables (quality, budget and timelines). He/She helps to introduce and develop patterns of work within the clinical research group to support and enhance the delivery of clinical development objectives and achievement of clinical excellence by encouraging a team-based approach.

Requirements

Approximately 3-6 years' experience in a similar position
Advanced knowledge of Statistics and the drug development process applied to clinical studies
High knowledge of international standards (ICH, GCP, CDISC …) and regulatory submission experience (FDA, EMA, etc.)
Proficiency with statistical software tools such as SAS, R, S-Plus, EAST, JMPC, etc.
High level of expertise of oversight and management of external vendors
Ability to manage projects/study: plan activities and tasks, identify project constraints and dependencies, identify and mitigate risks, report on project status, produce progress metrics and communicate efficiently with external vendors as well as internal partners
Ability to produce high quality, accurate work to meet deadlines
Ability to interact satisfactorily with staff of differing disciplines
Well-developed time management, communication, presentation, analytical and interpersonal skills
MS in statistics or biostatistics is required
Fluent in English (verbal and written)

Nice To Haves

Approximately 2-4 years' experience as statistician in clinical research
PhD in statistics or biostatistics is prefered

Responsibilities

Take responsibility as a statistical adviser to global project teams and clinical study teams for appropriate project development and make contributions to the statistical work for other projects as required.
Ensure that, in conjunction with the Early/Medical Development Director, and other groups (e.g. Pharmacokinetics) clinical development plans have a high quality, timely and robust statistical input.
Ensure that clinical study protocols are developed with statistical input as early as possible, and that statistical review and approval of other relevant study documents (e.g. Data handling plan, Randomisation plan, SAP and TLF Shell, Clinical Study report), is conducted to high quality, robust, rigorous, objective standards.
Lead project and study level activities with support from external vendors' statisticians.
Provide statistical input for selection and evaluation of external vendors and take responsibility for ensuring that the Service Provider statistical deliverables meet project specifications, and that they are produced to defined quality, content and timetable standards, and to liaise with the Purchasing Manager, to facilitate the achievement of timely, relevant, robust contracts and schedules of works.
Ensure that the Clinical Development Department has the functional specifications, quality standards and statistical input to the Service Provider evaluation and management process in a time frame and in accordance with clinical study team outsourcing strategy.
Co-ordinate the clinical research components of regulatory activities with respect to statistical methods, results and evaluation in such a way as to eliminate the chances of unsuccessful regulatory submissions. Provide the written and verbal elements of regulatory submissions around the world.
Plan, schedule and track all statistical activities, to ensure high quality, timely and accurate completion of statistical deliverables.
Present statistical methods used in clinical studies to Regulatory bodies when required: this includes the FDA and EMA as well as national bodies as appropriate.
Manage the Statistical input to the regulatory review process, addressing Regulatory Bodies questions in a timely technically sound and clearly presented manner.
Work closely with Data Management staff, within the Ipsen Group to ensure the timely availability of integrated quality databases to support ISS and ISE and the regulatory review process.
Be responsible in conjunction with other Statisticians for increasing the awareness of clinical research staff in R&D groups in all Ipsen companies, of the importance of maintaining statistical rigor in the clinical research processes.
Develop Statistical processes within the Ipsen Group by working with other statistician colleagues (i.e. Modelling and Simulation).
Develop, implement or advise on appropriate new statistical developments by keeping abreast of current issues and developments in statistical theory and application.
Maintain a good network of contacts with outside bodies relevant to clinical statistics, both within the EU and North America.
Complete all the above activities within the framework and in compliance with R&D SOPs and other documentation in force within the Ipsen Group.