Statistical Programmer

Innovation Statistics Compassion Life Sciences Data Modeling Collaboration SAS (Software) Pharmaceuticals Clinical Trials Computer Science Pharmacodynamics Pharmacokinetics Telephone Skills Data Manipulation Data Preprocessing Statistical Methods Applied Mathematics Reporting Processes Project Stakeholders Contingent Workforce Statistical Modeling Computer Programming Database Programming Clinical Pharmacology Statistical Programming Relationship Management Research And Development R (Programming Language) User Requirements Documents Very Large Databases (VLDB) Interpersonal Communications Python (Programming Language) Systems Development Life Cycle Software Development Life Cycle, This position provides high quality statistical programming deliverables for global stakeholders in Early Development Statistics and/or PK/PD Modeling and Simulation spanning all our Company's therapeutic areas. The senior statistical programmer will gather and interpret user requirements for programming requests, retrieve required data, transform data into analysis/modeling datasets, and develop tables, listings and figures according to statistical/modeling analysis plan. The senior programmer will partner with stakeholders to solve problems; reduce the amount of programming tasks being completed by stakeholders to facilitate an increase in efficiency and compliance for the analyses. The senior programmer will also write programs to analyze data with statistical methods which are not currently available through commercial software packages. The programmer will be a key collaborator with statisticians, pharmacokinetic (PK) modelers, and other project stakeholders.

Primary Activities :

• Programmatically develop, validate and maintain complex datasets, tables, listings, and figures
• Provide technical consultation and analytical support to statisticians and PK modelers for exploratory and unplanned statistical analyses
• Prepare compliant programming code for regulatory submissions including analysis datasets, tables, listings, figures and associated documentation
• Ensure programmatic traceability from data source to analysis / modeling result
• Support the development of programming standards to enable efficient and high quality production of programming deliverables, Senior Statistical Programmer Merck & Co., Inc North Wales, PAOn-Site Leadership Innovation Statistics Compassion Life Sciences Data Modeling Collaboration SAS (Software) Pharmaceuticals Clinical Trials Computer Science Pharmacodynamics Pharmacokinetics Telephone Skills Data Manipulation Data Preprocessing Statistical Methods Applied Mathematics Reporting Processes Project Stakeholders Contingent Workforce Statistical Modeling Computer Programming Database Programming Clinical Pharmacology Statistical Programming Relationship Management Research And Development R (Programming Language) User Requirements Documents Very Large Databases (VLDB) Interpersonal Communications Python (Programming Language) Systems Development Life Cycle Software Development Life Cycle +0 Senior Statistical Programmer Merck & Co., Inc North Wales, PAOn-Site Leadership Innovation Statistics Compassion Life Sciences Data Modeling Collaboration SAS (Software) Pharmaceuticals Clinical Trials Computer Science Pharmacodynamics Pharmacokinetics Telephone Skills Data Manipulation Data Preprocessing Statistical Methods Applied Mathematics Reporting Processes Project Stakeholders Contingent Workforce Statistical Modeling Computer Programming Database Programming Clinical Pharmacology Statistical Programming Relationship Management Research And Development R (Programming Language) User Requirements Documents Very Large Databases (VLDB) Interpersonal Communications Python (Programming Language) Systems Development Life Cycle Software Development Life Cycle

• BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 5-9 years SAS/R 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/R programming experience in a clinical trial environment

Department Required Skills and Experience:

• 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

Specific Required Skills and Experience:

• Experience in CDISC SDTM and ADaM standards
• Significant SAS or R programming experience for data manipulation, analysis and reporting
• Designs and develops complex programming algorithms
• Ability to comprehend analysis plans which may describe methodology to be programmed; understanding of statistical terminology and concepts; Implements statistical methods not currently available through commercial software packages
• Demonstrated ability to work in an exploratory environment, handling non-standard data in a variety of formats with minimal requirements; knowledge of pharmaceutical development processes

Preferred Skills and Experience:

• Programming expertise with pharmacokinetic data (raw concentration data, derived PK parameters)
• Familiarity with clinical pharmacology concepts and pharmacokinetics concepts
• Efficiently manipulates very large databases including complex data preprocessing, filtering, and manipulation; programming expertise with clinical endpoint data (efficacy and safety) and pharmacokinetic data (raw concentration data, derived PK parameters)
• Experience with at least one other software than SAS (e.g., R, Python, NonMem)
• Good working knowledge of reporting processes (SOPs) and software development life-cycle (SDLC)
• Utilizes and contributes to the development of standard departmental SAS macros
• Ability and interest to work across cultures and geographies
• Ability to complete statistical programming deliverables through the use of global outsource partner programming staff
• Active in professional societies, Clinical Database Programming, Clinical Trials, Collaborative Development, Data Modeling, Pharmaceutical Development, Project Leadership, Stakeholder Relationship Management, Statistical Programming

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.

Learn more about your rights, including under California, Colorado and other US State Acts

The salary range for this role is $117,000.00 - $184,200.00

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.