at Merck in Dover, Delaware, United States
Job Description
Job Description
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.
We are seeking a Growth and Improvement minded Senior Statistical Programmer that can help drive our Strategic Operating Priorities:
+ Invent | Pursue the Most Promising Internal and External Science to Address Significant Unmet Medical Needs
+ Execute | Prioritize Resources Behind Our Key Growth Drivers (Oncology, Vaccines, Select Specialty Areas, Animal Health) While Optimizing Our Base Business)
+ Adapt | Develop Our People, Culture and Business Model to Evolve with a Dynamic Landscape
+ Diverse Talent | We are committed to providing an inclusive and welcoming environment with supporting leadership behaviors because having a high-performing, engaged workforce is critical to our ability to deliver innovative solutions to patients and customers around the world
+ Values and Standards | Our Steadfast Commitment to Our Values and Standards will Continue to Guide Us as We Take on New Challenges and Will Always be Fundamental to Our Success – They are a Competitive Advantage for Us
Summary, Focus and Purpose
The Senior Statistical Programmer supports statistical programming activities for late stage drug/vaccine clinical development projects and 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 and 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 Functions
+ Work Independently and as a Team member with Integrity | Precision | Accomplishment | Motivational Ambition | Respect | Inclusion
+ Effective analysis and report programming development and validation utilizing global and TA standards and following departmental standard operating procedures (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
Education
+ BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus five to nine years SAS programming experience in a clinical trial environment
+ MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus three to seven years SAS programming experience in a clinical trial environment
Required
+ Effective interpersonal skills and ability to negotiate and collaborate effectively.
+ Principled written and verbal communications 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
+ 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
+ Ensure 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
+ Demonstrated success in the assurance of deliverable quality and process compliance. Strong working knowledge of reporting processes standard operating procedures (SOPs) and software development life-cycle (SDLC)
+ United States and/or worldwide drug or vaccine regulatory application submission experience including the development of electronic submission deliverables
+ 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
+ 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” 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.
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.
Residents of Colorado
Click here (https://survey.sogosurvey.com/Survey1.aspx?k=SsQYWYYQsQRsPsPsP&lang=0) to request this role’s pay range.
**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 vaccin
