Merck Senior Statistical Programmer, Late Stage Development in North Wales, Pennsylvania
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
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
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., Rahway, 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 …
Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today
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.
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For positions located in the United States and Puerto Rico – Subject to applicable law, all new hires (including internal transfers) must demonstrate that they are fully vaccinated against COVID-19 or that they qualify for a medical or religious exemption to this vaccination requirement. New hires (including internal transfers) to a position that, as determined by the Company, requires routine collaboration with external stakeholders (such as roles in health services or customer-facing commercial or research-based roles) (“Customer-Facing Role”) who are not vaccinated must qualify for a medical or religious exemption and be in a position that the Company determines can accommodate unvaccinated employees without causing an undue burden to business operations. If, following dialog with the candidate as appropriate, it is determined that the candidate either a) does not qualify for a religious or medical exemption or, b) for candidates applying for Customer-Facing roles, it is determined that allowing the candidate to work without vaccination would cause an undue burden to the Company, the candidate will be ineligible for hire or transfer, or any offer of employment or transfer (if applicable) will be revoked. Please note that notwithstanding the approval of any reasonable accommodation, the Company reserves the right to monitor, modify, or revoke any such accommodation if it is determined, following dialog with the employee, that the accommodation is no longer effective or results in an undue burden to the Company.
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Under New York City law, the Company is required to provide a reasonable estimate of the salary range for this job. 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 salary range:
$96,700.00 - $164,500.00
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Requisition ID: R213673
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