Bio Statistician - Pharma

- The job tasks listed below outline the scope of the position. The application of these tasks may vary, based upon current business needs.

- Statistical Trial Design and Analysis

- Operate in collaboration with study personnel to provide input on study protocol, design studies and write protocols for the conduct of each study.

- Assist in or be accountable for selecting statistical methods for data analysis, authoring the corresponding sections of the protocol, and conducting the actual analysis once a reporting database is created.

- Collaborate with data management in the planning and implementation of data quality assurance plans.

- Maintain currency with respect to statistical methodology, to maintain proficiency in applying new and varied methods, and to be competent in justifying methods selected.

- Participate in peer-review work products from other statistical colleagues.

- Communication of Results and Inferences

- Collaborate with team members to write reports and communicate results.

- Assist with, or be 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.

- Respond to regulatory queries and to interact with regulators.

- Therapeutic Area Knowledge

- Understand disease states in order to enhance the level of customer focus and collaboration and be seen as a strong scientific contributor.

- Regulatory Compliance

- Perform 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

Other Information/Additional Preferences:

- Statistics, Biostatistics, or equivalent of field study

- Proficient in the SAS programming language

- Interpersonal communication skills for effective customer consultation

- Teamwork and leadership skills

- Technical growth and application with working knowledge of experimental design and statistics

- Self-management skills with a focus on results for timely and accurate completion of competing deliverables

- Resource management skills

- Creativity and innovation

- Demonstrated problem solving ability and strategic thinking

- Business process expertise associated with critical activities (e.g. regulatory submissions)