OPEN JOB: Senior Advisor - BioStatistics
LOCATION: Indianapolis, Indiana
***Relocation Assistance Available
INDUSTRY: Pharmaceutical / Biotech
JOB CATEGORY: Research & Development

FIRM: Fortune 500 Pharmaceutical Firm
 

• The Clinical Project Statistician develops or assists in the development of protocol designs, clinical plans, and data analysis plans in collaboration with physicians, clinical research scientists, and other research colleagues. 
• The Clinical Project Statistician is responsible for working with research associates and scientists to establish a reporting database and for analyzing data for clinical studies.

PRIMARY RESPONSIBILITIES:
Statistical Trial Design and Analysis

• Provide input on study protocol, design studies and write protocols for the conduct of each study.
• Be accountable for selecting statistical methods for data analysis, authoring the corresponding sections of the protocol and the statistical analysis plan, and conducting the actual analysis once a reporting database is created.
• Collaborate with data sciences in the planning and implementation of data quality assurance plans.
• Maintain currency with respect to statistical methodology, maintain proficiency in applying new and varied methods, and to be competent in justifying methods selected.
• Perform peer-review of work products from other statistical colleagues.
• Influence team members regarding appropriate research methods

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 interact with regulators.

Therapeutic Area Knowledge

• Understand disease states, competitive landscapes, and regulatory environment 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.

Statistical Leadership and Teamwork

• Introduce and apply innovative methodology and tools to solve critical problems.
• Merge scientific thinking and business knowledge to identify issues, evaluate options and implement solutions.
• Lead projects independently and work effectively across functions. Apply technical expertise to influence business decisions.

MINIMUM QUALIFICATION REQUIREMENTS:

• Ph.D. in Statistics OR Biostatistics with at least 3 years of experience in Clinical Research and Development
• Proficient in statistical programming languages/software such as SAS, R, Spotfire, WinBUGs, etc.
• Interpersonal communication skills for effective customer consultation
• Teamwork and leadership skills
• Technical expertise and application with working knowledge of experimental design and statistical analysis
• 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 critical thinking

If you are interested in pursuing this opportunity, please respond back and include the following:

• Full Updated Resume
• Required Compensation
• Contact Information

Upon receipt, one of our managers will contact you to discuss in full

STEPHEN FLEISCHNER
Recruiting Manager
INTERMEDIA GROUP, INC.
EMAIL: sfleischner@intermediagroup.com