Sr. Scientist, Statistical Programming, Real World Evidence (Hybrid)

Job Description

In BARDS (Biostatistics and Research Decision Sciences) a distinguished department within our renowned Research and Development division quantitative scientists in partnership with other subject matter experts 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.

This position provides high quality statistical programming analysis and reporting and regulatory submission deliverables for Real World Evidence projects across our Company 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 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 andor R

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

• Unix operating system experience; SQL experience; systems and database experience

• 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 application submission experience including the development of electronic submission deliverables

• Experience eliciting user requirements and documenting programming specifications

• Team oriented with demonstrated history of teamwork and collaboration; enjoying diversity respect and integrity; Ability and interest to work across cultures and geographies

• An interest to advance career by investing in development activities and taking on tasks with increasing levels of challenge and responsibility

• Active in professional societies

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The salary range for this role is

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 employees 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 can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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