Job Description:
Senior Biostatistician, Early Development-BIO004222
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:
Developing, coordinating, and providing biostatistical support for related drug/vaccine projects under supervision in Late Development Statistics. The incumbent may initially work in the vaccine therapeutic areas.
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.
- Involves in research activities for innovative statistical methods and applications in clinical trial development.
- This position is for a Statistician who will contribute to efforts to 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.
- This position is for a Statistician who will contribute to efforts to 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 Requirement:
* Required: MS
* Preferred: Ph.D.
* Preferred: Concentration in Statistics / Biostatistics or related discipline
Required:
* With a Masters, a minimum of (3) years work related experience
* Demonstrated knowledge of statistical analysis methodologies and experimental design
* Working knowledge of statistical and data processing software e.g. SAS and/or R.
* Demonstrate strong interest in statistical research activities and in application of novel methods to clinical trial development.
* Ability to learn, be proactive and motivated, and consistently focus on details and execution.
* Strong oral and written communication skills
Preferred:
* Understanding of the Biology of Disease, as well as Drug Discovery and Development.
* Ability to work effectively with personnel with different functional background.
* 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:Sr. Scientist, Biostatistics
Primary Location: NA-US-NJ-Rahway
Employee Status: Regular
Travel: Yes, 5 % of the Time
Additional Info:
[Click Here to Access the Original Job Post]
Senior Biostatistician, Early Development-BIO004222
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:
Developing, coordinating, and providing biostatistical support for related drug/vaccine projects under supervision in Late Development Statistics. The incumbent may initially work in the vaccine therapeutic areas.
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.
- Involves in research activities for innovative statistical methods and applications in clinical trial development.
- This position is for a Statistician who will contribute to efforts to 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.
- This position is for a Statistician who will contribute to efforts to 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 Requirement:
* Required: MS
* Preferred: Ph.D.
* Preferred: Concentration in Statistics / Biostatistics or related discipline
Required:
* With a Masters, a minimum of (3) years work related experience
* Demonstrated knowledge of statistical analysis methodologies and experimental design
* Working knowledge of statistical and data processing software e.g. SAS and/or R.
* Demonstrate strong interest in statistical research activities and in application of novel methods to clinical trial development.
* Ability to learn, be proactive and motivated, and consistently focus on details and execution.
* Strong oral and written communication skills
Preferred:
* Understanding of the Biology of Disease, as well as Drug Discovery and Development.
* Ability to work effectively with personnel with different functional background.
* 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:Sr. Scientist, Biostatistics
Primary Location: NA-US-NJ-Rahway
Employee Status: Regular
Travel: Yes, 5 % of the Time
Skills :
Areas :
Additional Info:
[Click Here to Access the Original Job Post]