Job DescriptionOur Quantitative Sciences team use 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.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 Responsibilities:
Effective analysis and report programming development and validation utilizing global and therapeutic area (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 Minimum Requirements:
BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 5-9 years' SAS programming experience in a clinical trial environment.
MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 3-7 years' SAS programming experience in a clinical trial environment.
Required Experience and 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 Research and Development 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 Clinical Data Interchange Standards Consortium (CDISC) and Analysis Dataset Model (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 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).
United States 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” 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 …Merck & Co., Inc., Kenilworth, New Jersey, USA is known as “Merck” in the United States, Canada & Puerto Rico. We are known as “MSD” in Europe, Middle East, Africa, Latin America & Asia Pacific. We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products.We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world’s biggest investors in Research & Development.What we look for …In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.INVENT.IMPACT.INSPIRE.NOTICE FOR INTERNAL APPLICANTSIn 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.If you need an accommodation for the application process please email us at firstname.lastname@example.orgFor more information about personal rights under Equal Employment Opportunity, visit:EEOC Poster at https://www1.eeoc.gov/employers/upload/eeocselfprintposter.pdfEEOC GINA Supplement at https://www1.eeoc.gov/employers/upload/eeocginasupplement.pdfOFCCP EEO Supplement at https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCPEEOSupplementFinalJRFQA508c.pdfOFCCP Pay Transparency Rule at https://www.dol.gov/ofccp/pdf/pay-transp%20EnglishformattedESQA508c.pdfWe are an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.Search Firm Representatives Please Read CarefullyMerck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, 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:RegularRelocation:DomesticVISA Sponsorship:YesTravel Requirements:No Travel RequiredFlexible Work Arrangements:Flex TimeShift:Valid Driving License:Hazardous Material(s):NoNumber of Openings:3Requisition ID: R51270