Rahway, New Jersey

Job Description

Our Quantitative Sciences team uses big data to investigate the safety and efficacy claims of our potential medical breakthroughs. We review the quality and reliability of clinical studies using deep scientific knowledge, statistical study of decision-making in clinical trials. Accountability predominantly includes the development and execution of statistical study and reporting deliverables (e.g. safety and efficacy study of datasets, tables, listings, figures), the span of which range from individual clinical trials to world-wide regulatory application submissions. The incumbent is responsible for the design and maintenance of statistical datasets that Support multiple stakeholder groups. 

Responsibilities:

This position supports statistical programming activities for Early Oncology clinical development projects. This may include leadership of one or more projects.  Accountability predominantly includes the development and execution of statistical analysis and reporting deliverables (e.g., safety and efficacy analysis datasets, tables, listings, figures), Pharmacokinetics Pharmacodynamics (PKPD) deliverables for early oncology studies. The incumbent is responsible for the design and maintenance of statistical datasets that support multiple stakeholder groups which include clinical development, and safety evaluation. 

Primary Activities:

  • Effective analysis and report programming development and validation, utilizing global and therapeutic area  standards and following departmental standard operating procedures (SOPs) and good programming practice.

  • Maintain and manage a project plan including resource forecasting.

  • Coordinate the activities of a global programming team that includes outsourcing provider staff.

Education Requirement:

  • BA/BS preferably in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus a minimum of 5 years of SAS/R programming experience in a clinical trial environment

  • MS, preferably in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus a minimum of 3 years of SAS/R programming experience in a clinical trial environment

Required Skills and Experience:

  • Oncology programming experience

  • Designs and develops complex programming algorithms

  • Experience in Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM) and ADaM standards

  • Ability to comprehend analysis plans which may describe the methodology to be programmed; understanding of statistical terminology and concepts; Implements statistical methods not currently available through commercial software packages.

  • Excellent communication (oral, written) skills, interpersonal skills and ability to negotiate and collaborate effectively

  • Effective knowledge and experience in developing analysis and reporting deliverables for research and development projects (data, analyses, tables, graphics, listings)

  • A project leader; ability to collaborate with key stakeholders and completes tasks independently at a project level

  • Significant expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH

Preferred Skills and Experience:

  • Oncology trial experience, PK/PD experience

  • Good working knowledge of reporting processes and software development life-cycle (SDLC)

  • Utilizes and contributes to the development of standard departmental SAS macros

  • Ability and interest to work across cultures and geographies

  • Ability to complete statistical programming deliverables through the use of global outsource partner programming staff

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:

Yes

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1

Requisition ID:R83593

Rahway, New Jersey

Today's Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies, and consumer care and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships. For more information, visit www.merck.com.

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