Sr. Scientist, Stat. Programming - Real World Evidence (Hybrid)

Job Description

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 senior statistical programmer utilizes 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 using Real World Data.

In this role, the senior statistical programmer will gather and interpret user requirements from BARDS 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. The senior statistical programmer will be a key collaborator with BARDS epidemiologists and partner with study teams to effectively implement RWE standards to execute project plans efficiently.

Position Qualifications:                                                                               

Education Minimum Requirement:  

• MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related analytical field plus 3 yrs experience in SAS and\or R

• BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related analytical field plus 5 yrs experience in SAS and\or R

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 R&D projects (data, analyses, tables, graphics, listings)

• • A project leader; completes tasks independently at a project level, determines approach and ensures consistency, manages timelines

Position Specific Required Skills and Experience:  

• Significant expertise in SAS and\or R programming including data manipulation, statistical analysis, and graphics and tabulation techniques

• Designs and develops complex programming algorithms

• Ability to comprehend analysis plans which may describe observational research and statistical methodology to be programmed; an understanding of observational research or statistical terminology and concepts

• Experience ensuring process compliance and deliverable quality

• 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-practices

• Ability to anticipate stakeholder requirements

Preferred Experience and Skills:  

• 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 handling non-standard data in a variety of formats with minimal requirements

• 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

• Expertise in SAS and\or R Real World Evidence programming including data processing, statistical procedures and graphing and tabulation techniques; systems and database expertise; SQL experience; coding systems such ICD-9, ICD-10, CPT, NDC, LOINC; data standards like Common Data Model (CDM); version control tools

• Familiarity with the fields of Outcomes Research and Epidemiology including methodologies

• Solid RWE and RWD domain knowledge

• Experience in process improvement; utilizes and contributes to the development of standard departmental SAS macros, R packages and tools 

• Experience assuring programming consistency across protocols and projects, directing the program development effort of other programmers; experience as a programming mentor

• Familiarity with statistics, clinical and data management concepts as applied to drug/vaccine development within the pharmaceutical industry

• Demonstrated success in the creation of regulatory compliant CDISC ADaM standards, including mapping

• US and/or worldwide drug or vaccine regulatory