Senior Principal Scientist, Biostatistics Job
- Employer
- Merck
- Location
- Rahway NJ
- Closing date
- Jun 20, 2016
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Job Details
Senior Principal Scientist, Biostatistics-BIO004576
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.
- Leads, develops, coordinates, and provides biostatistical support for related drug/vaccine projects in Biometrics Research.
- Ensures that sound scientific principles and statistical methods are applied to designing and analyzing non-clinical trials or clinical studies in support of discovery and worldwide regulatory submissions.
- Leads the interaction with Clinical, Regulatory, Statistical Programming, Data Management, and other Merck Research Laboratories Scientists in designing and analyzing non-clinical and clinical trials, and in coordinating the statistical activities for drug/vaccine projects.
- Interacts with Academic Research Organization (ARO), Contract Research Organization (CRO) and external statistical consultants.
- Supervises statistical or programming staff assigned to a discovery or development project as needed.
Primary activities:
- Serves as statistical representative and lead in the cross-functional teams for the strategic planning and execution for product discovery and development
- Leads a team of statistical and/or programing staff assigned to a development project as needed
- Leads biostatistics in non-clinical or 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 non-clinical or clinical studies, proposes solutions and carries them out.
- Independently identifies opportunities to add value to drug/vaccine discovery and development programs.
- Develops individual protocols and data analysis plans and independently determines appropriate statistical methodology for analysis.
- 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 non-clinical or clinical studies to meet program objectives. Independently applies and implements basic and complex statistical techniques to these analyses. Prepares oral and written reports to effectively communicate results of non-clinical or clinical studies to the project team, Merck Management, regulatory agencies, or individual investigators.
- Represents biostatistics in regulatory interactions including presentation at advisory committee meetings
- Provides responses to queries relating to study design, analysis, and interpretation posed by the clinical monitors, regulatory agencies, and/or investigators.
- Participates with management in discussions with corresponding scientific personnel at regulatory agencies and with investigators concerning proposed or ongoing studies.
- Leads research activities for innovative statistical methods and applications in clinical trial development or drug development.
- Collaborates in publication of research results in areas of applications.
- Mentors and guides junior staff in functional activities.
- Participates in departmental activities including recruiting and training other statisticians, providing statistical training for non-statistical group and other committee work as needed.
Qualifications
Education:
- PhD or equivalent degree in statistics/biostatistics or related discipline with a minimum of 9 years relevant work experience, or a Master’s degree with a minimum of 12 years relevant work experience.
Required:
- Solid knowledge of statistical analysis methodologies and experimental design.
- Strong scientific leadership in design and analysis of clinical trials
- Strong project management skills.
- Solid knowledge of statistical and data processing software e.g. SAS and/or R.
- Solid understanding of worldwide regulatory requirements and all phases of drug/vaccine development.
- Excellent oral and written communication skills and strong leadership in a team environment.
- Demonstrated ability in statistical research activities and in application of novel methods to non-clinical or clinical studies.
- Publications in peer reviewed statistical/medical journals.
- Must also demonstrate the ability to learn, be proactive and motivated, and consistently focus on details and execution.
- Ability to collaborate with scientists and work on multi-discipline teams.
Preferred:
- An understanding of the biology of disease.
- Ability to work with large complex data sets.
- An understanding of risk and safety assessment.
- An understanding of modern techniques for statistical and/or machine learning.
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 staffingaadar@merck.com.
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.
For more information about personal rights under Equal Employment Opportunity, visit:
EEOC Poster
EEOC GINA Supplement
Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.
Job: Biostatistics
Job Title:Sr. Prin. Scientist, Biostatistics
Primary Location: NA-US-NJ-Rahway
Employee Status: Regular
Travel: Yes, 10 % of the Time
Number of Openings: 1
Shift (if applicable): 1st
Company Trade Name:Merck
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.
- Leads, develops, coordinates, and provides biostatistical support for related drug/vaccine projects in Biometrics Research.
- Ensures that sound scientific principles and statistical methods are applied to designing and analyzing non-clinical trials or clinical studies in support of discovery and worldwide regulatory submissions.
- Leads the interaction with Clinical, Regulatory, Statistical Programming, Data Management, and other Merck Research Laboratories Scientists in designing and analyzing non-clinical and clinical trials, and in coordinating the statistical activities for drug/vaccine projects.
- Interacts with Academic Research Organization (ARO), Contract Research Organization (CRO) and external statistical consultants.
- Supervises statistical or programming staff assigned to a discovery or development project as needed.
Primary activities:
- Serves as statistical representative and lead in the cross-functional teams for the strategic planning and execution for product discovery and development
- Leads a team of statistical and/or programing staff assigned to a development project as needed
- Leads biostatistics in non-clinical or 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 non-clinical or clinical studies, proposes solutions and carries them out.
- Independently identifies opportunities to add value to drug/vaccine discovery and development programs.
- Develops individual protocols and data analysis plans and independently determines appropriate statistical methodology for analysis.
- 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 non-clinical or clinical studies to meet program objectives. Independently applies and implements basic and complex statistical techniques to these analyses. Prepares oral and written reports to effectively communicate results of non-clinical or clinical studies to the project team, Merck Management, regulatory agencies, or individual investigators.
- Represents biostatistics in regulatory interactions including presentation at advisory committee meetings
- Provides responses to queries relating to study design, analysis, and interpretation posed by the clinical monitors, regulatory agencies, and/or investigators.
- Participates with management in discussions with corresponding scientific personnel at regulatory agencies and with investigators concerning proposed or ongoing studies.
- Leads research activities for innovative statistical methods and applications in clinical trial development or drug development.
- Collaborates in publication of research results in areas of applications.
- Mentors and guides junior staff in functional activities.
- Participates in departmental activities including recruiting and training other statisticians, providing statistical training for non-statistical group and other committee work as needed.
Qualifications
Education:
- PhD or equivalent degree in statistics/biostatistics or related discipline with a minimum of 9 years relevant work experience, or a Master’s degree with a minimum of 12 years relevant work experience.
Required:
- Solid knowledge of statistical analysis methodologies and experimental design.
- Strong scientific leadership in design and analysis of clinical trials
- Strong project management skills.
- Solid knowledge of statistical and data processing software e.g. SAS and/or R.
- Solid understanding of worldwide regulatory requirements and all phases of drug/vaccine development.
- Excellent oral and written communication skills and strong leadership in a team environment.
- Demonstrated ability in statistical research activities and in application of novel methods to non-clinical or clinical studies.
- Publications in peer reviewed statistical/medical journals.
- Must also demonstrate the ability to learn, be proactive and motivated, and consistently focus on details and execution.
- Ability to collaborate with scientists and work on multi-discipline teams.
Preferred:
- An understanding of the biology of disease.
- Ability to work with large complex data sets.
- An understanding of risk and safety assessment.
- An understanding of modern techniques for statistical and/or machine learning.
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 staffingaadar@merck.com.
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.
For more information about personal rights under Equal Employment Opportunity, visit:
EEOC Poster
EEOC GINA Supplement
Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.
Job: Biostatistics
Job Title:Sr. Prin. Scientist, Biostatistics
Primary Location: NA-US-NJ-Rahway
Employee Status: Regular
Travel: Yes, 10 % of the Time
Number of Openings: 1
Shift (if applicable): 1st
Company Trade Name:Merck
Company
Our vision is to make a difference in the lives of people globally through our innovative medicines, vaccines, biologic therapies, consumer health and animal products. We aspire to be the best healthcare company in the world and are dedicated to providing leading innovations and solutions for tomorrow.
We have made it our mission to provide innovative, distinctive products and services that save and improve lives, satisfy customer needs and to be recognized as a great place to work
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