Principal Biostatistician, Late Development Statistics

Organization
Merck
Job Location
Rahway, NJ
Job Description

Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company - one that is ready to help create a healthier future for all of us. 
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you'll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career. 
Responsibilities: 

•Serves as a statistical lead in project teams. 
•Develops, coordinates, and provides biostatistics leadership and support for related drug/vaccine projects in Late Development Statistics. 
•Interacts with Clinical, Regulatory, Statistical Programming, Data Management, and other Merck Research Laboratories Scientists in designing and analyzing clinical trials, and in coordinating the statistical activities for clinical drug/vaccine projects. 
•May interact with Academic Research Organization (ARO), Contract Research Organization (CRO) and external statistical consultants. 
The incumbent may initially work in Oncology, but experience in these areas is not a requirement.
Primary activities:

•Serves as statistical representative and lead in the cross-functional teams for the strategic planning and execution for product development 
•Is involved in clinical development planning to ensure that study designs are consistent with program objectives and meet worldwide regulatory and marketing needs. 
•Independently identifies and anticipates technical or other potential problems arising in the design, conduct, and analysis of clinical trials, proposes solutions and carries them out. 
•Develops individual protocols and data analysis plans and independently determines appropriate statistical methodology for analysis. 
•Participates in database design meetings to ensure that the data evaluated are in high quality and satisfy analysis requirements. 
•May lead a team of statisticians and 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 statistical techniques to these analyses. 
•Prepares oral and written reports to effectively communicate results of clinical trials to the project team, Merck 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. 
•May represent biostatistics in regulatory interactions including presentation at advisory committee meetings 
•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. 
•Mentors and guides junior staff in functional activities 

Requirements: 

Education: 

•PhD or equivalent degree in statistics/biostatistics or related discipline with a minimum of 6 years relevant work experience, or a Master's degree with a minimum of 9 years relevant work experience. 
Required: 

•Solid knowledge of statistical analysis methodologies and experimental design. 
•Strong project management skills; Solid knowledge of statistical and data processing software e.g. SAS and/or R. 
•Good understanding of worldwide regulatory requirements and clinical trial expertise from phase II to IV. 
•Strong oral and written communication skills. Able to function effectively in a team environment. 
•Demonstrates 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:

•Publications in peer reviewed statistical/medical journals. An understanding of biology of disease and drug discovery and development. 
Our employees are the key to our company's success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company's benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. If you need an accommodation for the application process please email us at [email protected]
Search Firm Representatives Please Read Carefully: 
Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means. 
Visa sponsorship is not available for this position.

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