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Associate Principal Scientist - Statistical Programming (Hybrid)

Job DescriptionNew hires in office-based roles in the US & Puerto Rico will be required, subject to applicable law,-to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption to this vaccination requirement that can be accommodated without an undue burden to the operation. However, subject to applicable law, employees working in roles that the Company determines require routine collaboration with external stakeholders, such as employees in health services, customer facing commercial, or research based roles, will be required to be fully vaccinated as a condition of employment.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 breakthroughPosition Description: The Associate Principal Scientist Statistical Programming leads the statistical programming activities for multiple and/or large/complex late stage drug/vaccine clinical development 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 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: Bachelor's or Master's (preferred) Degree or equivalent in Computer Science, Statistics, Applied Mathematics, Biological Sciences, or Engineering-Required Experience and Skills: BS plus minimum 9 years or MS plus minimum 7 years SAS programming experience in a clinical trial environmentExperience leading large and/or complex statistical programming projects that include coordinating the activities of a programming teamBroad 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.US and/or worldwide drug or vaccine regulatory application submission experience at the leadership level including the development of electronic submission deliverablesStrong 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 stakeholdersAbility 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 best-practicesExperience in CDISC and ADaM standards.Demonstrated success in the assurance of deliverable quality and process compliance.Ability to anticipate stakeholder and regulatory requirementsPreferred Experience and Skills:Strong working knowledge of reporting processes (SOPs) and software development life-cycle (SDLC)Ability and interest to work across cultures and geographies.Experience providing technical and/or programming guidance and mentoring to colleaguesAbility to complete statistical programming deliverables through the use of global outsource partner programming staffExperience developing and managing a project plan using Microsoft Project or similar packageActive in professional societiesExperience in process improvementWe 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.-VETJOBSBARDS2020Who we are ... We are known as Merck & Co., Inc., Kenilworth, 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 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.We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together.-The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.Residents of Colorado Click here 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 vaccinated for COVID-19 or qualify for a medical or religious exemption to this vaccination requirement that can be accommodated without an undue burden to the operation. However, subject to applicable law, employees working in roles that the Company determines require routine collaboration with external stakeholders, such as employees in health services, customer facing commercial, or research based roles, will be required to be fully vaccinated as a condition of employment.Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only:Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. For more information about personal rights under Equal Employment Opportunity, visit: EEOC Poster EEOC GINA Supplement- OFCCP EEO Supplement Pay Transparency Nondiscrimination We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace. Search Firm Representatives Please Read Carefully-Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, 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:Yes Travel Requirements: Flexible Work Arrangements:Flex TimeShift:Valid Driving License:Hazardous Material(s):Number of Openings: 1Requisition ID:R181234
Salary: . Date posted: 07/01/2022