Job Description

Job Description

Our Engineers support internal and external manufacturing operations remain operational, continuously improve and innovate. With our extensive range of facilities and environments, our Engineers have opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation.

Direct a team of professionals that are skilled and capable of providing expertise in the design and application of statistical and mathematical methods to the our company). The incumbent will, individually and through assignment of staff, provide statistical expertise on experimental design, and the evaluation and interpretation of data. The incumbent will also direct staff in the evaluation of data for submission to regulatory agencies and pharmacopoeia. The person will serve on various company task forces and outside industry groups to influence regulatory policies.

Primary Activities

* Objectively collects, organizes and summarizes data for projects. Performs basic statistical techniques such as ANOVA models, process capability and control, linear regression, ANCOVA for stability studies. Generates a wide variety of statistical graphics adapted to the need of the statistical project.
* Applies basic and advanced statistical techniques and graphics and recognizes the need for more sophisticated methods. Develops or adapts sophisticated techniques to meet the needs of specific projects.
* Writes or adapts basic statistical programs to perform studies and to create graphics. Performs simulations (e.g. Monte Carlo techniques).
* Directs and mentors junior staff members in the application of basic and advanced methods and graphics. Prepares and conducts training courses and seminars throughout MMD to familiarize scientists and management personnel in the comprehension of statistical techniques and methods.
* Proposes design of experiments and analysis plans through consultation with MMD personnel and teams. Contributes to the generation of objectives and hypotheses to be evaluated via statistical studies.
* Prepares oral and written reports to effectively conveys study designs and the interpretation of analyses.
* Conducts second person reviews of the formal reports of other CMS members. Performs data verifications to ensure compliance with auditing regulations for all data evaluated for a project that results in a second person reviewed report.
* Reviews literature and attends appropriate seminars and classes in order to develop and maintain the necessary skill levels. Contributes talks to professional society and/or industry meetings. Stays abreast of the advances made in statistics as well as the field of computer applications and brings the relevant advances into departmental practices.
* Participates on internal and external teams providing expertise. Evaluates the impact of new regulatory proposals to our company operations. Through involvement in external groups, helps shape regulatory policies. Through internal teams, provides direction in establishing guidance to the central departments and manufacturing sites.
* Within and outside of CMS, strategically develops and implements innovative ways to deal with opportunities; tests the status quo and drives new initiatives.
* Provides guidance and influence to staff, as appropriate, on all primary activities listed above. Ensures team members complete appropriate training prior to performing tasks. Manages and conducts reviews of direct reports performance against project goals and development objectives.

Qualifications:

Education Minimum:

* BS with >15 years experience, MS with >10 years experience, PhD with >5 years experience.

Preferred Experience and Skills:

* The scope of technical skills expected is broad, including design of experiments, linear and nonlinear models, and univariate/multivariate statistical process control.
* Outstanding statistical computing skills with substantial experience in at least two of the following statistical software packages:
* SAS, R/S Plus, JMP, Minitab.
* Exceptional oral and written communication skills to convey statistical concepts and analyses to non-statisticians.

Experience and Skills:

* Requires demonstrated resourcefulness and the established ability to develop and implement innovative and new concepts/ideas.
* Established and recognized ability for managing and initiating change.
* Requires demonstrated direction, ability to manage multiple projects/tasks simultaneously with influencing priorities.
* Requires established ability to guide cross-functional teams effectively, motivate people, delegate appropriately and resolve conflicts.
* Requires proven group management skills, the ability to develop clear performance objectives, accurately assess strengths and developmental needs of employees; and effectively train and develop all team members to meet their potential.
* Requires established ability to provide developmental feedback and coaching.
* Requires advanced business and financial knowledge.

Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network thats devoted to delivering a high quality, reliable supply to customers and patients on time, every time.

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.

Residents of Colorado

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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:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.
For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster

EEOC GINA Supplement

OFCCP EEO Supplement

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 anothers thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

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:

Yes

Travel Requirements:

10%

Flexible Work Arrangements:

Flex Time, Remote Work

Shift:

1st - Day

Valid Driving License:

Yes

Hazardous Material(s):

Number of Openings:

1
Requisition ID:R107688