Biostatistician, Late Development Statistics

** Job Description
** In BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our company’s renowned Research and Development division, quantitative scientists, in partnership with other subject matter experts, apply state-of-the art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for the benefit of patients and global human health.
** Responsibilities:
*** Develops, coordinates, and provides biostatistical support for related drug/vaccine projects under supervision in Late Development Statistics.
* Interacts with Clinical, Regulatory, Statistical Programming, Data Management and other our Company's Research Laboratories Scientists in analyzing clinical trials, and in coordinating other statistical activities for clinical drug/vaccine projects under supervision.
* The incumbent may initially work in a specific disease therapeutic area.
** Primary activities:
*** Shadowing senior statisticians, serves as statistical representative in the cross-functional teams for the clinical trial planning, execution, and reporting.
* Under supervision of senior statisticians, participates in study design; performs sample size calculations and simulations to support protocol development.
* Under supervision develops statistical analysis plans and determines appropriate statistical methodology for data analysis.
* Participates in database design meetings and reviews relevant study documents including CRF, Data Validation Plan, and Medical Monitoring plan to ensure that the data evaluated are in high quality and satisfy analysis requirements.
* Collaborates with the statistical programming staff to provide definitions, documentations, and reviews derived variables needed for planned analysis; ensures that all programs meet analysis requirements, internal standard operating procedures, and external regulatory requirements.
* Analyzes data and interprets results from clinical trials to meet objectives of the study protocol.  Reviews study results to ensure all the deliveries in high quality.
* Under supervision of senior statisticians, prepares oral and written reports to effectively communicate results of clinical trials to the project team, management, regulatory agencies, or individual investigators.
* Involved in research activities for innovative statistical methods and applications in clinical trial development
** Education and Minimum Requirement:
*** Master’s degree or equivalent in statistics/biostatistics or related discipline.
** Required

Skills and Experience:

*** Knowledge of statistical analysis methodologies and experimental design.
* Familiar with  statistical and data processing software e.g. SAS and/or R.
* Good oral and written communication skills. Able to work effectively with personnel with different functional background.
* Must also demonstrate the ability to learn, be proactive and motivated, and consistently focus on details and execution.

BARDS
2020#eligibleforERP
*
* Required Skills:

** Biological Sciences, Biostatistics, Clinical Reporting, Clinical Trial Management Processes, Clinical Trials, Clinical Trials Analysis, Communication, Data Analysis, Data Management, Data Science, Numerical Analysis, Protocol Development, Regulatory Requirements, Scientific Modeling, Statistical Analysis, Statistical Analysis Plans, Statistical Programming, Statistics
** Preferred

Skills:

** Current Employees apply

Current Contingent Workers apply
** US and Puerto Rico Residents Only:
** Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please  if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.  As a federal contractor, we comply with all…