Senior Scientist, Statistical Programming

MSD; Rahway (NJ); On-site; USD 117,000 - 184,000; Full time

Job summary

MSD in Rahway, NJ is seeking a Senior Scientist, Statistical Programming to support late-stage drug/vaccine clinical development. You will develop and execute analysis datasets, tables, listings and figures across trials and regulatory submissions.

The role requires advanced SAS programming skills, CDISC/ADaM experience, and the ability to lead projects and collaborate with cross-functional teams to deliver high-quality deliverables on time.

Qualifications

• Master’s degree or Bachelor’s degree with relevant SAS experience in clinical trials.
• Experience with CDISC and ADaM standards.
• Expertise in SAS programming including data steps and procedures.
• Ability to design programming solutions and ensure deliverable quality.

Responsibilities

• Provide support to statistical programming activities for late-stage development.
• Develop and execute analysis datasets, tables, listings, figures for trials and regulatory submissions.
• Design and maintain statistical datasets for multiple stakeholders.
• Lead one or more projects and collaborate with stakeholders.

Skills

SAS programming

Statistical analysis

Project leadership

Communication

Education

Master’s degree in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field

Bachelor’s degree + 5 years SAS programming experience in clinical trials

Tools

SAS

SAS/MACRO

SAS/GRAPH

CDISC

ADaM

Job description

Job Description

Senior Scientist, Statistical Programming – Rahway, NJ:

• Provide support to statistical programming activities for late-stage drug/vaccine clinical development projects.
• Be accountable for 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.
• Design and maintain statistical datasets that support multiple stakeholder groups which include clinical development, outcomes research and safety evaluation.
• Act as a key collaborator with statistics and other project 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.
• 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.
• Lead one or more projects.

Requirements

• Must have a Master’s degree (or US equivalent) in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 3 years experience in SAS programming in a clinical trial environment OR a Bachelor’s degree (or US equivalent) in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 5 years experience in SAS programming in a clinical trial environment.
• Experience in CDISC and ADaM standards.
• Experience in designing and developing complex programming algorithms and ensuring process compliance and deliverable quality.
• Must possess expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH.
• Systems and database expertise.
• Must have ability to comprehend analysis plans which may describe methodology to be programmed.
• Have an understanding of statistical terminology and concepts; strategic thinking ability to turn strategy into tactical activities.
• Ability to 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.
• Familiarity with clinical data management concepts.
• Effective interpersonal skills and ability to negotiate and collaborate effectively.
• Written, oral, and presentation skills.
• Knowledge and experience in developing analysis and reporting deliverables for R&D projects (data, analyses, tables, graphics, listings) also required.
• Must be a project leader and possess ability to complete tasks independently at a project level.
• Ability to collaborate with key stakeholders.

Required Skills

Clinical Development, Clinical Trials, Computer Science, Data Management, Data Modeling, Global Health, Marketing, Numerical Analysis, Outcomes Research, Project Leadership, Stakeholder Engagement, Stakeholder Relationship Management, Statistical Analysis, Statistical Programming, Strategic Thinking, Waterfall Model, Working Independently

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: Regular

Equal Employment Opportunity

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: EEOC Know Your Rights EEOC GINA Supplement.

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.

The salary range for this role is $117,000.00 - $184,200.00. 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 https://jobs.merck.com/us/en/compensation-and-benefits.

The application deadline for this position is stated on this posting.