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Senior Scientist, Biostatistics. Job in Rahway, New Jersey, United States in Merck & Co., Inc.. Nelest.com
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Senior Scientist, Biostatistics

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Job ID:

22132

Location:

Rahway, NJ 

Job function:

Project Management, Research & Development
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Posted:

03.05.2016

Employment Type:

Full time

Industry:

Healthcare / Pharma
col-wide   

Title:

Senior Scientist, Biostatistics

Job Description:

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:
  • Developing, coordinating, and providing biostatistical support for related drug/vaccine projects under supervision in Late Development Statistics.


Primary activities: This position involves interaction 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.

Specific 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.
  • Is involved in research activities for innovative statistical methods and applications in clinical trial development


Travel: Yes, 5 % of the Time Description Senior Scientist, Biostatistics-BIO004483 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:
  • Developing, coordinating, and providing biostatistical support for related drug/vaccine projects under supervision in Late Development Statistics.

Job Requirements:

Qualifications Education:
  • PhD or equivalent degree in statistics/biostatistics or related discipline, or Masters with a minimum of 3 years of relevant experience.


Required:
  • Knowledge of statistical analysis methodologies and experimental design.
  • Working knowledge of statistical and data processing software e.g., SAS and/or R.
  • Demonstrate interest in statistical research activities and in application of novel methods to clinical trial development.
  • Understanding of US and EU NDA filing requirements and standards (CDISC/ADAM).
  • Must also demonstrate the ability to learn, be proactive and motivated, and consistently focus on details and execution.


Preferred:
  • Excellent oral and written communication skills
  • Ability to work effectively with personnel with different functional background
  • 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 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. Visa sponsorship is not available for this position. 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.

Zip Code:

7065

Company Info
Merck & Co., Inc.

Kenilworth, NJ, United States

Phone:
Web Site: merck.com

Company Profile

Company Info


Merck & Co., Inc.
Kenilworth, NJ, United States
Phone:
Web Site: merck.com

Senior Scientist, Biostatistics

col-narrow-left   

Job ID:

22132

Location:

Rahway, NJ 

Job function:

Project Management, Research & Development
col-narrow-right   

Posted:

03.05.2016

Employment Type:

Full time

Industry:

Healthcare / Pharma
col-wide   

Title:

Senior Scientist, Biostatistics

Job Description:

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:
  • Developing, coordinating, and providing biostatistical support for related drug/vaccine projects under supervision in Late Development Statistics.


Primary activities: This position involves interaction 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.

Specific 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.
  • Is involved in research activities for innovative statistical methods and applications in clinical trial development


Travel: Yes, 5 % of the Time Description Senior Scientist, Biostatistics-BIO004483 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:
  • Developing, coordinating, and providing biostatistical support for related drug/vaccine projects under supervision in Late Development Statistics.

Job Requirements:

Qualifications Education:
  • PhD or equivalent degree in statistics/biostatistics or related discipline, or Masters with a minimum of 3 years of relevant experience.


Required:
  • Knowledge of statistical analysis methodologies and experimental design.
  • Working knowledge of statistical and data processing software e.g., SAS and/or R.
  • Demonstrate interest in statistical research activities and in application of novel methods to clinical trial development.
  • Understanding of US and EU NDA filing requirements and standards (CDISC/ADAM).
  • Must also demonstrate the ability to learn, be proactive and motivated, and consistently focus on details and execution.


Preferred:
  • Excellent oral and written communication skills
  • Ability to work effectively with personnel with different functional background
  • 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 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. Visa sponsorship is not available for this position. 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.

Zip Code:

7065
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