Job Abstract

Job Description

In BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our company's renowned Research and Development division, quantitative scientists, in partnership with other subject matter experts, apply state-of-the art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for the benefit of patients and global human health.

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.

• Membership on departmental strategic initiative teams

Educational Qualifications:

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

• MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field and at least 3 years SAS programming experience in a clinical trial environment.

Required Skills:

• 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 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.

• Ability to anticipate stakeholder requirements.

Preferred Experience:

• 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 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 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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