Priya Mukherjee at CK Clinical is recruiting for an Associate Director Biometrician required to work for
a leading pharmaceutical organisation in Switzerland.
The Associate Director Biometrician is responsible for providing expert statistical analytic solutions across multiple disease areas within a Franchise or equivalent and able to seamlessly move across the portfolio within a Franchise. They are responsible for statistical analytic support to clinical development programs, mentoring other biometricians stretching through to the full spectrum of capabilities
- Lead the statistical analytic contributions to the clinical development programs within a Franchise, in collaboration with the Statistical Scientist, comprising all relevant technical and disease area knowledge.
- Drive in developing statistical strategic quantitative contributions to regulatory/ submission strategy and related documents via expert statistical analytic solutions with excellent interface to the Statistical Scientist: Decision criteria, CSPDs, MAPs, project development strategy and trial designs, responses to HA questions.
- Be responsible for leading statistical analytic solutions for regulatory submissions and health authority interactions, by working with statistical scientists and programmers.
- Provide expert statistical analytic support to the Statistical Scientist in developing the pooling strategy specifically for compounds that are developed for multiple indications within a Franchise and develops the detailed statistical methodology for the MAP, CSPDs and attend submission planning meetings.
- Represent biometrics at the GPT meetings and other internal decisions boards in collaboration with the Statistical Scientist.
- Provide statistical computational expertise for scenarios simulations to optimize program/trial and analysis strategies through to sample size and probability of success calculations in collaboration with the Statistical Scientists for CDP writing.
- Provide expertise specifically to high complexity programs to execute the CSPD, advisory committee tables, figures and listings.
- Ensure high quality for all deliverables and processes.
- Foster efficient expert interfaces with internal and external customers with support of management.
- Drive statistical research in collaboration with statistical scientists and the commercial organization by providing expertise and trouble shooting on computational statistical aspects of the problem.
- Lead the statistical analytic solutions to the exploratory analyses.
- Define future directions for computational solutions / liaises with programming defining future generic code.
- Maintain strong and broad based statistical expertise – maintain knowledge of mainstream and newly emerging statistical /numerical techniques / algorithms.
- Take leadership in influencing internal discussions for white papers for general analytic practice internally and establishing external presence.
- Drive, steer and mentor others, and may undertake role of development/appraisal coordinator for selected Franchise associates.
Qualifications and skills:
To be considered for this Associate Director Biometrician role the successful candidate will have the following qualifications and experience:
- Proven in up-to-date statistical knowledge/ applications and expert in analytic aspects. A deep understanding of drug development and HA guidelines.
- Excellent knowledge of / experience with SAS/ R/ Splus or any other business or research analytic software
- Establish record in operating at program level
- Strong interpersonal and communication skills (verbal and written), strong disease area knowledge
- Strong team skills.
- Establish track record of trouble shooting skills including significant regulatory/ decision making support
- Natural modern leadership style building partnerships and collaborative environments.
For more information or to apply for this Associate Director Biometrician role please contact Priya Mukherjee on +44 (0) 2074 705 673 or email email@example.com. Please quote reference CL25348 in all correspondence.