Sr. Scientist, Statistical Programming- Hybrid

USA - New Jersey - Rahway

MSD

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Job Description

Position Description:

Responsibilities:

This position supports statistical programming activities for late stage drug/vaccine 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), the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support.

The incumbent is responsible for the design and maintenance of statistical datasets that support multiple stakeholder groups which include clinical development, outcomes research and safety evaluation.

The position is a key collaborator with statistics and other project stakeholders in ensuring that project plans are executed efficiently with timely and high quality deliverables.

For assigned projects the position serves as the statistical programming point of contact and knowledge holder through the entire product lifecycle.

Primary Activities:

  • Effective analysis and report programming development and validation utilizing global and TA standards and following departmental SOPs and good programming practices

  • Maintain and manage a project plan including resource forecasting 

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

Position Qualifications:

Education Minimum Requirement:

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

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

Required Experience and Skills:

Department Required Skills and Experience:

  • Effective interpersonal skills and ability to negotiate and collaborate effectively

  • Effective written, oral, and presentation skills

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

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

Position Specific Required Skills and Experience:

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

  • Designs and develops complex programming algorithms

  • Ability to comprehend analysis plans which may describe methodology to be programmed; an understanding of statistical terminology and concepts

  • Familiarity with clinical data management concepts

  • Experience in CDISC and ADaM standards

  • Experience ensuring process compliance and deliverable quality

  • 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.

Preferred Experience and Skills:

  • Demonstrated success in the assurance of deliverable quality and process compliance. Strong working knowledge of reporting processes (SOPs) and software development life-cycle (SDLC)

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

  • Experience assuring programming consistency across protocols and projects, directing the program development effort of other programmers; experience as a programming mentor

  • Ability and interest to work across cultures and geographies

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

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

  • Active in professional societies

  • Experience in process improvement

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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 separationpackage, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

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.

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The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. 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’s relevant skills, experience, and education.

Expected US salary range:

$111,400.00 - $175,300.00

Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here.

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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:

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Travel Requirements:

Flexible Work Arrangements:

Hybrid

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Job Posting End Date:

10/8/2024

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

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Category: Data Science Jobs

Tags: CDISC Computer Science Data management Engineering Mathematics R R&D Research SAS SDLC Statistics

Perks/benefits: Career development Flex hours Flex vacation Health care Insurance Relocation support Salary bonus Transparency

Regions: Remote/Anywhere North America
Country: United States

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