Senior Statistical Programmer Consultant

General Scope and Summary

The Senior Statistical Programmer Consultant is responsible for all statistical programming deliverables in support of the design, conduct, analysis, and reporting phase of one or more clinical trials. This individual will work independently to support various programming activities related to the analysis and reporting of clinical study data. The Senior Statistical Programmer Consultant may also serve as the statistical programming lead on one or more programs, working closely with other statistical programmers, study biostatistician and biostatistics program lead, study data manager, study medical writer, and other functional area study leads as required. General areas of responsibility also includeprogramming, specification development, analysis datasets (e.g., SDTM/CDISC, ADaM) creation, as well as mapping specifications to support relevant data standards. The main focus of this role will be on analysis/ADAM/TLFsprogramming and validation and ad hoc requests programming.

Roles and Responsibilities

• Develop SAS programs that generate datasets, complex listings, tables (including those with descriptive and standard inferential statistics in collaboration with a Statistician), and complex graphs.

• Develop SAS programs that support regulatory requests, ISS/ISE analyses, commercial requests, and biostatistical ad hoc analysis.

• May have to create SAS utility macros; write and implement test plans to support SAS macro development.

• Review and validate CRO deliverables.

• Lead and oversee programming activities performed by the CRO programming and biostatistics team.

• Review ADAM specs, datasets, define, and reviewers guide for multiple studies.

• Perform quality review on SAS programs generated by other statistical programmers.

• Help solve critical issues requiring SAS expertise.

• Understand and follow FDA regulations that affect the reporting of clinical trial data. This includes good clinical practice and guidelines for electronic submissions.

• Keep informed of SAS programming techniques as applied to clinical trials by reading relevant journals and/or attending courses/programming meetings.

• Assist in other programming tasks using software other than SAS (e.g., SQL) to support specialized data analysis requirements.

• Ensure that programs are documented in accordance with Good Statistical Programming Practices and other Working Guidelines.

• Work collaboratively as part of a team.

• Handle multiple priorities.

• Adapt to changing priorities, take initiative, and follow through on own.

• Be attentive to detail and independently resolve a variety of issues without close supervision.

• Be independent creative thinker.

• Have excellent interpersonal skills.

• Manage multiple projects/tasks and appropriately prioritize.

• Oversee programming work performed by Contract Research Organizations.

Experience, Education and Specialized Knowledge and Skills

• 8+ years of experience in pharmaceutical industry

• 10+ years of excellent SAS programming skills and extensive experience working with BASE SAS, SAS GRAPH, and SAS macro programming.

• Proficiency in statistical procedures(e.g., PROC FREQ, PROC REPORT, PROC GLM, PROC MIXED).

• In-depth knowledge of CDISC standards for SDTM, ADaM, and FDA electronic data submission requirements.

• Submission experience (including review of Defines/aDRGs).

• Understanding of SAS database structures and experience with at least one Clinical Database Management System (e.g., Medidata RAVE, Oracle inform, etc.).

• Excellent communication skills (verbal, written, and interpersonal).

• Regulatory submission programming is a plus.

• Ability to work well within multi-disciplinary teams and proven ability to coordinate and drive projects in a matrix organization.

• Embrace our core values: Put People First, Improve Lives, Cultivate Curiosity, Do Right, and Forge New Pathways.