Principal Statistical Programmer Real World Evidence

3 weeks ago


North Wales, United States Merck Sharp & Dohme Full time

This position provides high quality statistical programming analysis and reporting and regulatory submission deliverables for Real World Evidence projects across the company's Biostatistics and Research Decision Sciences (BARDS) group. The principal statistical programmer utilizes strong expertise in multiple programming languages including SAS and R to efficiently manipulate electronic healthcare databases to discover disease prevalence and risk factors, describe drug utilization patterns and disease progression, answer clinical development questions, and support regulatory submissions. In this role, the principal statistical programmer will gather and interpret user requirements from epidemiologists, retrieve the required data from electronic healthcare databases, and develop disease cohorts, analytical datasets, tables, figures, and submission deliverables and perform validation activities following departmental SOPs. This position also focuses on strategic activities impacting Real World Evidence projects to the direct benefit of project teams and the Biostatistics organization.

The position is a key collaborator with internal and external stakeholders including Epidemiology and other functional areas including those involved with regulatory submissions to execute project plans efficiently and oversee the work of other team members when opportunities arise.

**Position Qualifications**:
**Education Minimum Requirement**:

- MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related analytical field plus minimum 10 yrs experience in multiple programming languages including SAS and R
- BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related analytical field plus 12 yrs experience in multiple programming languages including SAS and R

**Required Experience and Skills**:

- Excellent interpersonal skills and ability to negotiate and collaborate effectively
- Excellent written, oral, and presentation skills
- Superior knowledge and significant experience in setting strategy and developing analysis and reporting deliverables for Research & Development projects (data, analyses, tables, graphics, listings)
- Excellent project management skills; leadership across multiple and complex programs; determines approach and ensures consistency and directs effort others; ability to engage key stakeholders.
- Significant expertise in SAS and R Real World Evidence programming including data processing, statistical procedures and graphing and tabulation techniques; systems and database expertise
- Solid RWE and RWD domain knowledge
- Designs and develops complex programming algorithms
- Ability to quickly and effectively learn new program techniques and data structures; capacity to seamlessly assimilate to new projects
- Familiarity with fields of Outcomes Research and Epidemiology and statistical analysis methods including observational research, terminology and concepts; implements observational methods not currently available through commercial software packages.
- Programming expertise with electronic healthcare databases (electronic medical records and insurance claims); efficiently manipulates large databases including complex data preprocessing, filtering, and manipulation; experience with sampling strategies for large databases
- Experience working with coding systems such ICD-9, ICD-10, CPT, NDC
- Unix operating system experience; SQL experience; systems and database experience
- Thrives working in an exploratory environment, handling non-standard data in a variety of formats with mínimal requirements
- Demonstrated success in the assurance of deliverable quality and process compliance. Strong working knowledge of reporting processes (SOPs) and software development life-cycle (SDLC)
- Experience assuring programming consistency across protocols and projects, directing the program development effort of other programmers; experience as a programming mentor
- Experience in process improvement; leads and contributes to the development of departmental standards and tools
- An interest to advance career by investing in development activities and taking on tasks with increasing levels of challenge and responsibility
- Team oriented with demonstrated history of teamwork and collaboration; enjoying diversity, respect and integrity

**Preferred Experience and Skills**:

- Experience in CDISC and ADaM standards, including mapping
- Experience with Common Data Model (CDM)
- Expertise in statistics, clinical and data management concepts as applied to drug/vaccine development within the pharmaceutical industry
- Experience in version control tools (e.g., git, Github)
- Ability to anticipate stakeholder requirements
- Ability and interest to work across cultures and geographies
- Active in professional societies

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