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Associate Principal Biostatistician Job

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Company: Science Careers

Location: Rahway, NJ

Date Posted: December 23, 2014

Source: Science Careers

Associate Principal Biostatistician-BIO004026

Description

Merck is a global health care leader with a diversified portfolio of prescription medicines, vaccines and consumer health products, 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 leadership and support for related drug/vaccine projects in Late Development Statistics. The incumbent may initially work in the Respiratory & Immunology therapeutic areas.

Primary Activities:

This position involves interaction with Clinical, Regulatory, Statistical Programming ...
Associate Principal Biostatistician-BIO004026

Description

Merck is a global health care leader with a diversified portfolio of prescription medicines, vaccines and consumer health products, 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 leadership and support for related drug/vaccine projects in Late Development Statistics. The incumbent may initially work in the Respiratory & Immunology 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. This position may serves as a statistical lead in project teams.

Specific activities include and are not limited to the following:

- 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.
- 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 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.
- 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.

Qualifications

Education:

- Required: MS
- Preferred: Ph.D.
- Preferred: Concentration in Statistics / Biostatistics or related discipline

Required Experience:

- With a Masters, a minimum of (6) years relevant work experience
- With a Ph.D., a minimum of (2) years relevant work experience
- Knowledge of solid statistical analysis methodologies and experimental design.
- Working 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.
- Demonstrate strong interest in statistical research activities and in application of novel methods to clinical trial development.
- Able to function effectively in a team environment.
- Must also demonstrate the ability to learn, be proactive and motivated, and consistently focus on details and execution.

Preferred Experience:

- Strong oral and written communication skills
- Solid project management skills
- Ability to work effectively with personnel with different functional background.
- Publications in peer reviewed statistical/medical journals
- Understanding of the Biology of Disease, as well as 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. 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:Associate Principal 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: 2

Shift (if applicable): 1st
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