25/01 Rita Yadav
Associate Consultant at Synergy Consultants

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Clinical Statistician - Pharma (3-10 yrs)

Bangalore Job Code: 20693


The Clinical Project Statistician develops or assists in the development of protocol designs, clinical plans, and data analysis plans in collaboration with physicians, veterinarians, and/or medical colleagues.

The Clinical Project Statistician is responsible for working with research associates and scientists to establish a reporting database and for analyzing data for these types of studies.

Key Responsibilities:

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

- Statistics, Biostatistics, or equivalent of field study

Other Information/Additional Preferences:

- 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)

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