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Job Description

Associate Principal Scientist, Statistical Programming - Rahway, NJ:

• Lead statistical programming activities for multiple and/or complex late-stage clinical trial development programs.
• Develop and execute 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.
• Act as a key collaborator with biostatisticians, project leads, data managers, and other stakeholders in ensuring that project plans are executed efficiently with timely and high-quality deliverables.
• Serve as the statistical programming point of contact and knowledge holder through the entire product lifecycle.
• Develop SAS and R programs to create and validate analysis datasets (ADaM) and summaries (TFLs) in support of clinical study reports and regulatory submissions (FDA, EMA, etc.).
• Responsible for assurance of deliverable quality and process compliance.
• Develop and maintain macro libraries (global and project-specific).
• Maintain and manage a project plan including resource forecasting.
• Coordinate activities of a global programming team that includes outsource provider staff.
• Act as a member on departmental strategic initiative project teams such as new statistical computing platform evaluation and development.

Education and Minimum Requirement:

• Must have a Bachelor's degree (or US equivalent) in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering, Pharmaceutical Sciences, or related field plus at least 9 years experience in Statistical Analysis System (SAS) programming in a clinical trial environment OR a Master's degree (or US equivalent) in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering, Pharmaceutical Sciences, or related field plus at least 7 years experience in Statistical Analysis System (SAS) programming in a clinical trial environment.
• Experience leading large and/or complex statistical programming projects for Phase 2 and 3 clinical trials, including coordinating the activities of a programming team.
• US and/or worldwide drug regulatory application submission experience at the leadership level including the development of electronic submission deliverables.
• Broad knowledge and significant experience in developing analysis and reporting statistical programming deliverables for clinical trials (datasets, statistical analyses, report tables, and graphics) using global and TA standards and according to quality, compliance and timeliness requirements.
• Expertise in CDISC and ADaM standards.
• Expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH; systems and database expertise.
• Must possess strong familiarity with statistical analysis methods and clinical data management concepts.
• Strong project management skills; demonstrated ability as a program leader.
• Ability to determine appropriate programming methodology, assure programming consistency across protocols and projects, complete programming tasks, and direct the program development effort of other programmers.
• Demonstrated success in the assurance of deliverable quality and process compliance.
• Must be an experienced programming mentor.
• Possess ability to engage key stakeholders.
• Must possess ability to comprehend statistical analysis plans which may describe statistical methodology to be programmed; an understanding of statistical terminology and concept designs and develop complex programming algorithms.
• Excellent communication and negotiation skills with a demonstrated history of teamwork and collaboration;
• Ability to deal well with change and seamlessly assimilate to new projects and stakeholders;
• Strategic thinking ability to turn strategy into tactical activities;
• Design statistical databases with the end in mind that optimize analysis and reporting and leverage departmental standards and industry best-practices;
• Ability to anticipate stakeholder and regulatory requirements.

The salary range for this role is

$144,373.00 - $224,100.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at Compensation and Benefits Webpage.

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Preferred Skills:

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US and Puerto Rico Residents Only:

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.

San Francisco Residents Only:We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only:We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance

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.

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