Job Description

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 Research Laboratories Scientists in designing and analyzing clinical trials, and in coordinating the statistical activities for clinical drug/vaccine projects.

The incumbent may initially work in a specific disease therapeutic area.

Primary activities:

·                     Serves as statistical representative in the cross-functional teams for the clinical trial planning, execution, and reporting.

·                     Develops individual protocols and data analysis plans and determines appropriate statistical methodology for data analysis.

·                     Participates in database design meetings to ensure that the data evaluated are in high quality and satisfy analysis requirements.

·                     Collaborates with the statistical programming staff to ensure that all programs meet analysis requirements, internal standard operating procedures, and external regulatory requirements.

·                     Evaluates appropriateness of available software for planned analyses and ascertains needs for potential program development of novel statistical methodology.

·                     Analyzes data and interprets results from clinical trials to meet objectives of the study protocol.  Independently applies and implements basic and complex techniques to these analyses.

·                     Prepares oral and written reports to effectively communicate results of clinical trials to the project team, management, regulatory agencies, or individual investigators.

·                     Provides responses to queries relating to study design, analysis, and interpretation posed by the clinical monitors, regulatory agencies, and/or investigators.

·                     Is responsible for planning and ensuring the accuracy of Statistical Review Aids submitted to regulatory agencies.

·                     Participates with management in discussions with corresponding scientific personnel at regulatory agencies and with investigators concerning proposed or ongoing studies.

·                     Involved in research activities for innovative statistical methods and applications in clinical trial development

Education & Skills

Education and Minimum Requirement:

PhD or equivalent degree in statistics/biostatistics or related discipline, with a minimum of 1 year relevant experience, or a Master’s degree with a minimum of 4 years relevant experience.

Required Skills and Experience:

·         Knowledge of statistical analysis methodologies and experimental design.

·         Working knowledge of 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.

·         Demonstrate strong interest in statistical research activities and in application of novel methods to clinical trial development.   

·         Must also demonstrate the ability to learn, be proactive and motivated, and consistently focus on details and execution.

Preferred Skills and Experience:

An understanding of biology of disease and drug discovery and development.

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Not Applicable

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

no

Job Posting End Date:

01/28/2025

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:R319777