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Must apply at:



Location: Franklin, Indiana


Required to work onsite at the Franklin Location.


The ideal candidate would have a master's degree or be close to completing a Master's in a statistical or data science field.



Education and/or Experience:

· M.S. or M.A. in statistical or data science field.

· Previous experience or undergraduate degree in life sciences preferred.

· Zero to two years related experience and/or training or equivalent combination of education and experience.

Principal Function: The Statistician I is responsible for providing statistical consulting services to internal and external clients. This position will primarily emphasize conducting statistical analyses to support the establishment of immunogenicity cut points for the detection and characterization of anti-drug antibodies. Position also includes statistical support of biomarker, assay development and CM&C projects as needed. The Statistician I completes or verifies analyses assigned to the Data Analytics Team, including cut points and clinical immunogenicity reporting. The individual in this role ensures quality and regulatory requirements for good laboratory practice (GLP) are followed when specified.


Essential Duties and Responsibilities:

· Work within a team setting to participate in the development of statistical methodology to support client projects and advance company capabilities.

· Use existing statistical software and a variety of established statistical methods to gather, analyze, and interpret data to derive useful information for research studies.

· Format data, develop and prepare reports, charts, tables, and other related documents and graphics.

· Primary analyses of data, including, but not limited to, cut point, clinical immunogenicity, laboratory datasets.

· Verifies results of primary analysis.

· Reviews reports created by the medical writer.

· Completes quality control (QC) of reports created by the medical writer.

· Collaborates on study designs and plate maps.

· Collaborates with clients on data analysis and interpretation of results.

· Creates publications of methods and results to include creating relevant datasets and programs.

· Contributes to standard operating procedures (SOPs) related to statistics.

· Participates in team meetings, project management meetings, and client meetings.

· Provides back-up for other members of the Stats Team.

· Keep up to date with new publications and methodologies used in immunogenicity, biomarker, CM&C, and pharmacokinetic statistical analysis.

· Other duties as assigned.




Other Skills and Abilities:

· Computer software skills including Microsoft Office Suite, SharePoint, and Paylocity.

· An in-depth knowledge of Statistical Analysis Software (SAS) or R programming language.

· The ability to maintain confidentiality.

· A working knowledge and understanding of global regulatory guidance documents and relevant industry whitepapers.

· A working knowledge of scientific concepts and terminology.

· A working knowledge of the pharmaceutical development process.

· A working knowledge of statistical research principles, methods, procedures, and standards.

· Perform analysis and interpretation of data from analytical instrumentation.

· Analyze, interpret, and evaluate data, and make determinations.

· Clearly and concisely present findings in oral, written, or electronic format.

· Format data, develop and prepare reports, charts, tables, and other related documents and graphics.

· The ability to explain statistical concepts and project results to non-statisticians.

· The ability to work in a team environment with colleagues from other disciplines including senior scientists, medical writers, QC/QA, project managers, and scientific staff.

· Interact professionally and constructively with clients, team members, and co-workers.

· Work alone with minimum supervision and with others in a team environment.

· Document daily work in an accurate, concise, and timely manner.

· Keep up to date with new publications and methodologies used in immunogenicity, biomarkers, CM&C and pharmacokinetic statistical analysis.

· The ability to be sensitive to professional ethics, gender, cultural diversities and disabilities.

· Apply standard office practices and organizational skills to a variety of interrelated processes, tasks, and operations.

· The ability to travel out-of-town on Company business and/or to attend or speak at conferences and training events.

· A working knowledge of basic laboratory procedures is desired.


Physical Demands

· Ability to stand less than 1/3 of the time.

· Ability to walk less than 1/3 of the time.

· Ability to sit more than 2/3 of the time.

· Ability to talk or hear from 1/3 to 2/3 of the time.

· Ability to lift 20 lbs. less than 1/3 of the time.