Job Description

Job Description

Our Quantitative Sciences team use big data to analyze the safety and efficacy claims of our potential medical breakthroughs. We review the quality and reliability of clinical studies using deep scientific knowledge, statistical analysis and high-quality data to support decision making in clinical trials.

Responsibilities:

* Serve as a statistical representative and core member in the Risk Management Safety Teams. Serve as the primary point of contact in clinical safety statistics for a therapeutic area.
* Lead, coordinate, and provide statistical support for drug/vaccine projects in Clinical Safety Statistics
* Lead the interaction with Safety Physicians, Clinical Monitors, Regulatory, Early/Late Development Statistics and other company Research Laboratories Scientists in the planning and execution of ongoing safety evaluation across pre-marketing and post-marketing development stages
* Lead or contribute to the structured benefit-risk evaluation projects
* Lead or contribute to the safety analysis for HTA submissions

Primary activities:

* Serve as statistical lead on cross-functional safety teams and engage in strategic planning and scientific reasoning that facilitates safety and benefit-risk evaluations.
* Plan and execute ongoing aggregate safety evaluations, including a cumulative meta-analysis of safety. Have a team leadership role in coordinating and ensuring that all deliverables meet analysis requirements, standard operating procedures, and regulatory requirements.
* Engage with regulatory agencies worldwide on statistical issues associated with the aggregate review of safety data. May represent Biostatistics in regulatory interactions regarding product safety evaluation, including a presentation at advisory committee meetings.
* Prepare oral and written reports to effectively communicate results of safety and benefit-risk evaluations to the project teams, management, regulatory agencies, or individual investigators.
* Support safety evaluations for health technology assessments (HTA).
* Take a lead role in the design, development and application of safety and benefit-risk evaluation methods, tools and processes.
* Mentor and guide junior staff.

Education:

* PhD or equivalent degree in statistics/biostatistics or related discipline with a minimum of 9 years relevant work experience, or Masters with a minimum of 12 years relevant work experience.

Required:

* Solid knowledge of statistical analysis methodologies, including survival analysis, meta-analysis and Bayesian analysis.
* Knowledge and experience with clinical trial design and analysis
* Experience with the analysis and interpretation of integrated safety data
* Strong project management skills.
* Solid knowledge of statistical and data processing software e.g. SAS and/or R. Familiarity with Visual Analytical Software (e.g., R*Shinny) a plus.
* Good understanding of worldwide regulatory requirements and clinical trial expertise from phase I to V.
* Strong oral and written communication skills; ability to function effectively in a team environment with personnel from different functional areas.
* Strong interest in statistical research activities and in application of novel methods to clinical safety evaluation.

Preferred:

* Publications in peer-reviewed statistical/medical journals.
* An understanding of the biology of disease and drug discovery and development
* Knowledge of regulatory requirements regarding the analysis and reporting of safety data.

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we follow the science 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

We are known as Merck & Co., Inc., Kenilworth, 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

In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.

INVENT.

IMPACT.

INSPIRE.

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.

US and Puerto Rico Residents Only:

If you need an accommodation for the application process please email us at staffingaadar@msd.com
For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster

EEOC GINA Supplement

OFCCP EEO Supplement

OFCCP Pay Transparency Rule

We are an equal opportunity employer, Minority/Female/Disability/Veteran proudly embracing diversity in all of its manifestations.

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, 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:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Not Specified

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1
Requisition ID:R95940