Associate Principal Scientist, Statistical - North Wales, United States - Merck Sharp & Dohme

Mark Lane

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Mark Lane

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Description
Our Research Scientists are our Inventors. We identify and target steps in disease mechanisms or pathways that could be inhibited or enhanced. Our goal is to isolate a compound that is effective against a disease target. Using innovative thinking, state-of-the-art facilities and robust scientific methodology we collaborate to discover the next medical breakthrough.


Position Description:


The incumbent is responsible for the design and maintenance of statistical databases 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.


Key areas of focus include:

- the assurance of deliverable quality and process compliance,
- effective deliverable development utilizing global and TA standards that optimize analysis and reporting and promote a strategic knowledge-base data model,
- maintaining and managing a project plan including resource forecasting,
- coordinating the activities of a global programming team that includes outsource provider staff,
- membership on departmental strategic initiative project teams such as new statistical computing platform evaluation and development.


Position Qualifications:


Education Minimum Requirement:


  • BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field with a minimum of 9 years Statistical Analysis System (SAS) programming experience in a clinical trial environment.
  • MS (preferred) in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field with a minimum of 7 years Statistical Analysis System (SAS) programming experience in a clinical trial environment.

Required Experience and Skills:


  • Experience leading large and/or complex statistical programming projects that include coordinating the activities of a programming team.
  • Broad 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, SAS/MACRO, SAS/GRAPH; systems and database expertise. Familiarity with statistical analysis methods and clinical data management concepts.
  • Strong project management skills; A program leader; Determines 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; Understanding of statistical terminology and concepts Designs and develops complex programming algorithms.
  • Excellent 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 bestpractices.
  • Experience in CDISC and ADaM standards.
  • Demonstrated success in the assurance of deliverable quality and process compliance.
  • Ability to anticipate stakeholder and regulatory requirements.

Preferred Experience and Skills:


  • Strong working knowledge of reporting processes (SOPs) and software development lifecycle (SDLC)
  • Ability and interest to work across cultures and geographies.
  • Experience 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
  • Experience developing and managing a project plan using Microsoft Project or similar package
  • Active in professional societies
  • Experience in process improvement
eligibleforERP

BARDS2020

SPjobs


EBRG

VETJOB

NOTICE
FOR
INTERNAL
APPLICANTS


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.

**Employees working in roles that the Company determines requi

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