Job Description:
Principal Scientist, Biostatistics-BIO004173
Description
Merck is a global health care leader with a diversified portfolio of prescription medicines, and vaccines, as well as 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 people 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 biostatistical 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. Interacts with regulatory agency, Clinical Research Organizations, Academic Research Organization and external statistical consultants relating to study design, analysis, and interpretation of clinical trials. The incumbent may initially work in a specific disease area.
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. Involves in research activities for innovative statistical methods and applications in clinical trial development. Mentors and guides junior staff in functional activities. Enhance the use of advanced molecular technologies such as genome wide association genetics, gene expression and in the discovery of novel biomarkers in clinical trials. Qualifications
Education:
Required: MS Preferred: Ph.D. Required:
With a Masters, a minimum of (9) years’ relevant work experience. With a Ph.D. (or equivalent degree), a minimum of (6) years’ relevant work experience in statistics/biostatistics or related discipline. 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 V. Strong oral and written communication skills. Able to function effectively in a team environment. 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:
Publications in peer reviewed statistical/medical journals. An understanding of biology of disease and drug discovery and development. Ideally, the candidate will have a background in molecular profiling with the ability to apply creative thinking and development of original concepts in terms of both statistics and genetics. Ability to utilize and interpret bioinformatics tools would be an extra bonus. 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. Merck’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 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.
ZZ5ML
Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.
Job: Biostatistics
Job Title: Prin. Scientist, Biostatistics
Primary Location: NA-US-NJ-Rahway
Other Locations: NA-US-PA-Upper Gwynedd
Employee Status: Regular
Travel: Yes, 5 % of the Time
Number of Openings: 1
Shift (if applicable): 1st
Additional Info:
[Click Here to Access the Original Job Post]
Principal Scientist, Biostatistics-BIO004173
Description
Merck is a global health care leader with a diversified portfolio of prescription medicines, and vaccines, as well as 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 people 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 biostatistical 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. Interacts with regulatory agency, Clinical Research Organizations, Academic Research Organization and external statistical consultants relating to study design, analysis, and interpretation of clinical trials. The incumbent may initially work in a specific disease area.
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. Involves in research activities for innovative statistical methods and applications in clinical trial development. Mentors and guides junior staff in functional activities. Enhance the use of advanced molecular technologies such as genome wide association genetics, gene expression and in the discovery of novel biomarkers in clinical trials. Qualifications
Education:
Required: MS Preferred: Ph.D. Required:
With a Masters, a minimum of (9) years’ relevant work experience. With a Ph.D. (or equivalent degree), a minimum of (6) years’ relevant work experience in statistics/biostatistics or related discipline. 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 V. Strong oral and written communication skills. Able to function effectively in a team environment. 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:
Publications in peer reviewed statistical/medical journals. An understanding of biology of disease and drug discovery and development. Ideally, the candidate will have a background in molecular profiling with the ability to apply creative thinking and development of original concepts in terms of both statistics and genetics. Ability to utilize and interpret bioinformatics tools would be an extra bonus. 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. Merck’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 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.
ZZ5ML
Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.
Job: Biostatistics
Job Title: Prin. Scientist, Biostatistics
Primary Location: NA-US-NJ-Rahway
Other Locations: NA-US-PA-Upper Gwynedd
Employee Status: Regular
Travel: Yes, 5 % of the Time
Number of Openings: 1
Shift (if applicable): 1st
Skills :
Areas :
Additional Info:
[Click Here to Access the Original Job Post]