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Associate Principal Scientist, Statistical Programmer | Oncology

Merck Cherokee

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Rahway, NJ
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Job Description

As posted by the hiring company

Job Overview:

Job Description

New hires based in the US & Puerto Rico will be required to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption or accommodation to this vaccination requirement, subject to applicable law.

Our Quantitative Sciences team uses 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.

The Associate Principal Scientist, Statistical Programming-Oncology leads the statistical programming activities for multiple and/or large/complex late stage drug/vaccine clinical development projects. Accountability predominantly includes the development and execution of statistical analysis and reporting deliverables (e.g., safety and efficacy analysis datasets, tables, listings, figures), the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support. Key areas of focus include: (1) the assurance of deliverable quality and process compliance, (2) effective deliverable development utilizing global and therapeutic area (TA) standards that optimize analysis and reporting and promote a strategic knowledge-base data model, (3) maintaining and managing a project plan including resource forecasting, (4) coordinating the activities of a global programming team that includes outsource provider staff, and (5) membership on departmental strategic initiative project teams such as new statistical computing platform evaluation and development.

Additional Responsibilities

  • Design and maintenance of statistical databases that support multiple stakeholder groups which include clinical development, outcomes research and safety evaluation

  • Key collaborator with statistics and other project stakeholders in ensuring that project plans are executed efficiently with timely and high quality deliverables

  • Serves as the statistical programming point of contact and knowledge holder through the entire product lifecycle for assigned projects

Education Requirements

  • BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 9-12 years SAS programming experience in a clinical trial environment
  • MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 7 or more years SAS programming experience in a clinical trial environment

Experience and Skills

Required

  • Directing large and/or complex statistical programming projects that include coordinating the activities of a programming team

  • Expansive knowledge and significant experience in 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

  • Expertise in SAS and clinical trial programming including data steps, procedures, MACRO, SAS/GRAPH; systems and database expertise | Familiarity with statistical analysis methods and clinical data management concepts

  • United States and/or worldwide drug or vaccine regulatory application submission knowledge at the leadership level including the development of electronic submission deliverables.

  • Strategic, effective and strong project management skills

  • Program Leader who establishes appropriate programming methodology, assures programming consistency across protocols and projects, completes programming tasks, and directs the program development effort of other programmers; an experienced programming mentor; ability to engage key stakeholders

  • Ability to comprehend statistical analysis plans which may describe statistical methodology to be programmed

  • Comprehension of statistical terminology and concepts Designs and develops complex programming algorithms

  • Principled and effective communication and negotiation skills with a demonstrated history of teamwork and collaboration; deals well with change and seamlessly assimilates to new projects and stakeholders

  • Strategic thinking - ability to turn strategy into tactical activities; design of statistical databases with the end in mind that optimize analysis and reporting and leverage departmental standards and industry best-practices

  • CDISC and ADaM standards skills

  • Demonstrated success in the assurance of deliverable quality and process compliance

  • Ability to anticipate stakeholder and regulatory requirements

Preferred

  • Strong working knowledge of reporting processes, standard operating procedures (SOPs) and software development life-cycle (SDLC)

  • Ability and interest to work across cultures and geographies

  • Providing technical and/or programming guidance and mentoring to colleagues

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

  • Developing and managing a project plan using Microsoft Project or similar package

  • Active in professional societies

  • Process improvement

​We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” and that great medicines can make a significant impact to our world. And 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.

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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.

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.

New hires in office-based roles in the US & Puerto Rico will be required, subject to applicable law, to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption to this vaccination requirement that can be accommodated without an undue burden to the operation. However, subject to applicable law, employees working in roles that the Company determines require routine collaboration with external stakeholders, such as employees in health services, customer facing commercial, or research based roles, will be required to be fully vaccinated as a condition of employment.

Current Employees apply HERE

Current Contingent Workers apply HERE

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

Pay Transparency Nondiscrimination

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.

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:

No Travel Required

Flexible Work Arrangements:

Flex Time, Work Week

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

3