Job Description

In BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our 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.

Responsibilities:

This position focuses on strategic activities impacting late stage development therapeutic area (TA) projects to the direct benefit of project teams and the Biostatistics organization.

The position is a key collaborator with internal and external stakeholders including Statistics, Clinical Research, Regulatory, Observational Research, Clinical Safety and PK/PD Modeling and Simulation organizations.

Primary Activities:

Address operational challenges that require strategic solutions, resulting in improved CSR and filing completion timelines worldwide

Lead development of TA-specific standard Tables, Listings, Figures (TLF) libraries

Facilitate global adoption of TA standards and programming best practices

Contribute to strategic solutions in support of internal stakeholder groups including the Outcomes Research and Clinical Safety organizations

Lead and actively contribute to departmental strategic initiative project teams

Education and Minimum Requirement:

BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 12-15 years SAS programming experience in a clinical trial environment

MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 10 or more years SAS programming experience in a clinical trial environment

Department Required Skills and Experience:

Excellent interpersonal skills and ability to negotiate and collaborate effectively

Excellent written, oral, and presentation skills

Superior knowledge and significant experience in setting strategy and developing analysis and reporting deliverables for R&D projects (data, analyses, tables, graphics, listings)

Excellent project management skills; leadership across multiple and complex programs; determines approach and ensures consistency and directs effort others; ability to engage key stakeholders

Position Specific Required Skills and Experience:

Expertise in SAS and clinical trial programming

Superior knowledge and significant experience in setting strategy and developing analysis and reporting statistical programming deliverables (datasets, statistical analyses, report tables, and graphics) using global and TA standards and according to quality, compliance and timeliness requirements

US and/or worldwide drug or vaccine regulatory application submission experience at the leadership level including the development of electronic submission deliverables

Designs and develops complex programming algorithms

Familiarity with statistical analysis methods, terminology and concepts

Familiarity with clinical data management concepts

Experience in CDISC and ADaM standards

Demonstrated success in the assurance of deliverable quality and process compliance

Strategic thinking - ability to analyze operational activities and challenges and develop and implement strategic solutions

Ability to anticipate stakeholder requirements

Ability and interest to work across cultures and geographies

** Preferred Skills and Experience:

Experience developing and implementing statistical programming standards

Experience in process assessment, improvement and operational excellence methodologies

Strong working knowledge of reporting processes (SOPs) and software development life-cycle (SDLC)

Experience developing and managing a project plan using Microsoft Project or similar package

Active in professional societies

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We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we \xe2\x80\x9cfollow the science\xe2\x80\x9d that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

Who we are \xe2\x80\xa6

We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world\'s most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for \xe2\x80\xa6

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us\xe2\x80\x94and start making your impact today.

NOTICE FOR INTERNAL APPLICANTS

In accordance with 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.

Residents of Colorado

to request this role\xe2\x80\x99s pay range.

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.

Current Employees apply

Current Contingent Workers apply

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please if you need an accommodation during the application or hiring process.

We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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\xe2\x80\x99s thinking and approach problems collectively.

U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as \xe2\x80\x9cremote\xe2\x80\x9d.

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\xe2\x80\x99s relevant skills, experience, and education.

Expected salary range: $159,200.00 - $250,700.00

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 .

Search Firm Representatives Please Read Carefully
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

Merck & Co.