Principal Programmer Cover Letter

I would like to submit my application for the principal programmer opening. Please accept this letter and the attached resume.

In my previous role, I was responsible for timely and scientifically sound statistical expertise to clinical development projects and develop/execute statistical strategy, design, and analyses for clinical trials.

My experience is an excellent fit for the list of requirements in this job:

• Focused on and motivated to provide excellent customer service
• Serve as lead statistical programmer to support the clinical programs, review or contribute to study protocols, statistical analysis plans (SAPs) and table, listing, figure (TLF) shells, Independent Data Monitoring Committee (IDMC), data analysis and Clinical Study Reports (CSRs) as appropriate
• Write and maintain documentation and changes to SAS code, programs, and specifications
• Develop/review TLFs and ADaM specifications in collaboration with biostatisticians and other clinical development colleagues
• Provide input on Case Report Form (CRF) design, CRF annotation, edit checks, integrated data review plans, and Study Data Tabulation Model (SDTM) specifications as needed
• Contribute to the development and implementation of standard programming practices and SOPs
• Create/Review Define XML, Define PDFs, Reviewers Guides, OpenCDISC validation report
• Provide programming support for interim/Adhoc analysis, publication and DMC

I submit this application to express my sincere interest in the principal programmer position.

In the previous role, I was responsible for key contributions to the analytical and clinical studies in the program, including but not limited to protocol development, statistical analysis plans, and data reporting.

Please consider my qualifications and experience:

• Develop and maintain study level programs to create operational study level data structures for downstream end to end use by multiple consumers ensuring alignment across studies within the same compound
• Create and maintain consumer areas and/or data marts for the provision and use of data
• Ensure that standard development and testing techniques are used and that all solutions are of the highest quality and conform to all SOPs, OIs and Best Practice Documents
• Facilitate requirements gathering from consumers and develop solutions to meeting immediate and long-term needs of business customers
• Perform compliance of study structure against standard library definitions
• Collaborate with study team functional representatives to ensure a sound understanding of the technical platforms for standardized solutions to study related requests or issues
• Complete documentation associated with programming tasks in compliance with applicable SOPs, OIs and Best Practice Documents
• Participate and actively contribute to process definition and documentation of Best Practices and/or step by step guides

Please consider me for the principal programmer opportunity. I am including my resume that lists my qualifications and experience.

In my previous role, I was responsible for statistical guidance on the development of Study Design Concepts, Protocols, Statistical Analysis Plans, Data Presentation Plans, Clinical Study Reports and publication activities in support of BPM clinical/observational study activities.

I reviewed the requirements of the job opening and I believe my candidacy is an excellent fit for this position. Some of the key requirements that I have extensive experience with include:

• Provide oversight of statistical programming activities of vendors
• Participate in the development and maintenance of Sponsor’s oversight Standard Operating Procedures (SOPs) for statistical programming
• Excellent knowledge in CDISC standards (CDASH, SDTM, ADaM, eSub), working knowledge of CDISC SDTM Implementation Guidelines, ADaM Implementation Guidelines
• Prior service leadership in of the following areas
• Vendor management experience at the enterprise scale
• Prior experience in management of multiple vendor environments
• Familiarity with Global Sourcing strategies
• Prior experience in vendor selection, RFI, and RFP preparation

I am excited to be applying for the position of principal programmer. Please accept this letter and the attached resume as my interest in this position.

In the previous role, I was responsible for statistical support with minimal supervision in the development and review of the study synopsis, protocol, statistical analysis plan, clinical study report, and other regulatory submission documents, ensuring accurate and statistically valid deliverables.

My experience is an excellent fit for the list of requirements in this job:

• Understand and measure vendor and service provider metrics
• Complete documentation associated with programming tasks
• Recommend strategies to avoid or minimize operational problems identifies opportunities for efficiency gains and develops proposals to realize them
• Superior knowledge and significant experience in setting strategy and developing analysis and reporting deliverables for R&D projects (data, analyses, tables, graphics, listings)
• Superior knowledge and significant experience in setting strategy and developing analysis and reporting statistical programming deliverables (datasets, statistical analyses, report tables, and graphics) using global and TA standards and according to quality, compliance and timeliness requirements
• US and/or worldwide regulatory application submission experience at the leadership level including the development of electronic submission deliverables
• Familiarity with statistical analysis methods, terminology and concepts
• Document and maintain study level specifications for data transformations ensuring a high level of consistency and quality within and across studies

Please consider me for the principal programmer opportunity. I am including my resume that lists my qualifications and experience.

Previously, I was responsible for advanced input into the statistical sections and overall consistency of the protocol and clinical study report.

I reviewed the requirements of the job opening and I believe my candidacy is an excellent fit for this position. Some of the key requirements that I have extensive experience with include:

• Participate and actively contribute to cross functional process optimization initiatives
• Participate in Knowledge Sharing forums within the group and across the organization
• Assist with the training of new programmer(s) or temporary staff
• Experience considered higher weight over educational background
• Advanced knowledge of data warehousing principles, technologies and related ETL processes
• Experience in performing ETL tasks and validating results
• Knowledge of clinical data mapping, transformation and end to end processes
• Experience working with clinical data in a relational database