Associate Principal Scientist, Biostatistics (Hybrid)

Job Description

In BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our company's renowned Research and Development division, quantitative scientists, in partnership with other subject matter experts, apply state-of-the art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for the benefit of patients and global human health.

We are seeking Growth and Improvement minded Associate Biostatistics Principal Scientist that can help drive our Strategic Operating Priorities.

• Invent | Pursue the Most Promising Internal and External Science to Address Significant Unmet Medical Needs
• Execute | Prioritize Resources Behind Our Key Growth Drivers (Oncology, Vaccines, Select Specialty Areas, Animal Health) While Optimizing Our Base Business)
• Adapt | Develop Our People, Culture and Business Model to Evolve with a Dynamic Landscape
• Diverse Talent | We are committed to providing an inclusive and welcoming environment with supporting leadership behaviors because having a high-performing, engaged workforce is critical to our ability to deliver innovative solutions to patients and customers around the world
• Values and Standards | Our Steadfast Commitment to Our Values and Standards will Continue to Guide Us as We Take on New Challenges and Will Always be Fundamental to Our Success - They are a Competitive Advantage for Us

Summary, Focus and Purpose

The Associate Biostatistics Principal Scientist develops, coordinates, and provides biostatistical leadership and support for related drug/vaccine projects in Late Development Statistics.

You will interact with Clinical, Regulatory, Statistical Programming, Data Management, and other Company Research Laboratories Scientists in designing and analyzing clinical trials, and in coordinating the statistical activities for clinical drug/vaccine projects and may interact with Contract Research Organization (CRO).

This position may serve as a statistical lead in project teams and may initially work in a specific disease area.

Key Functions

• Work Independently and as a Team member with Integrity | Precision | Accomplishment | Motivational Ambition | Respect | Inclusion
• Serves as statistical representative and lead in the cross-functional teams for the strategic planning and execution for product development
• 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 verbal 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
• 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
• Involved in research activities for innovative statistical methods and applications in clinical trial development
• Mentors and guides junior staff in functional activities

Education

• PhD or equivalent degree in statistics/biostatistics or related discipline with three years relevant work experience or a Master degree with six years relevant work experience

Experience | Skills | Knowledge

Required

• Solid knowledge of 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
• Principled verbal 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
• Demonstrate the ability to learn, be proactive and motivated, and consistently focus on details and execution

Preferred

• Publications in peer reviewed statistical/medical journals
• Solid project management skills. An understanding of biology of disease and drug discovery and development

NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

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Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

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We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

U.S. Hybrid Work Model

Effective September 5,2023 our U.S. Hybrid work model will be as follows: 1. Three total days on site per week: Tuesday and Wednesday - plus one additional day of choice based on what works best for organizations and/or teams. 2. Fridays will formally be a remote-working day unless business critical tasks require onsite presence.

Under New York City, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education.

Expected salary range:
$130,960.00 - $206,200.00

Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here.

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Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:
Regular

Relocation:
Domestic

VISA Sponsorship:
Yes

Travel Requirements:
10%

Flexible Work Arrangements:
Hybrid

Shift:
1st - Day

Valid Driving License:
No

Hazardous Material(s):
n/a

Requisition ID:R253185