Senior Statistician/Programmer-- Office based at Walter Reed Army Institute in Silver Spring, MD!

Thermo Fisher Scientific • Rockville, MD

2d • $112,000 - $143,000 • Onsite

About The Position

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future. What will you do in this role? Act as the lead statistician & programmer on selected studies of moderate complexity, working directly with project team leaders and client representatives to assess and develop project goals and timelines. Assume leadership responsibility as a contributing member of a multi-disciplinary clinical trials project team, communicating actively and frequently with other team members as needed. Independently create, execute, maintain, and validate programs that transfer data across multiple data management systems or operating systems, combine data from a variety of sources and structures, generate and store summary data from a variety of sources, generate reports or combine multiple databases and validate programs that generate listings, tables and figures using SAS. Manage and document assignments to meet timelines and deliver high quality work, being familiar with any relevant contractual obligations or limits. Increase knowledge base and professional skills in areas including programming, technology and techniques, clinical trials, and the pharmaceutical industry. This is a Sr Statistician role that will have programming responsibilities, as well. As the lead Sr Statistician that will program, your responsibilities will include: Managing and analyzing large, complex, and diverse clinical datasets. Study design, statistical strategy, data standardization, analysis, and reporting. Conduct Statistical Programming and Validation of SDTM and ADaM datasets Generate Define.XML files for SDTM and ADaM datasets, and prepare the SDRG and ADRG Create annotated CRFs to map data collection fields to SDTM variables. Perform Statistical Analysis as outlined in the SAP. Compile TLFs for inclusion in the Final Clinical Study Report (FCSR) Comply with Quality Assurance and Compliance, following FDA CDISC standards and guidance. Metadata and Documentation Generate Define.XML files for SDTM and ADaM datasets Prepare the Study Data Reviers’s Guide (SDRG) for SDTM datasets Prepare the Analysis Data Reviewer’s Guide (ADRG) for ADaM datasets Annotate the Case Report Form (CRF) to map data collection fields to SDTM variables Final Clinical Study Report (FCSR) Compile statistical analysis results and Tables, Listings and Figures (TLFs) into the FCSR for regulatory submission

Requirements

• Master's degree in statistics, biostatistics or math is required. In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
• At least 3 years of experience that provides the knowledge, skills, and abilities to perform the job requirements.
• Experience managing and analyzing large, complex, and diverse clinical datasets is required.
• Experience with study design, statistical strategy, data standardization, analysis, and reporting is required.
• Experience conducting Statistical Programming and Validation of SDTM and ADaM datasets is required.
• Experience and proven capability in performing statistical analyses in strict accordance with the Statistical Analysis Plan (SAP), study protocol, and applicable regulatory guidance is required.
• Experience producing and validating Tables, Listings and Figures (TLFs) is required.
• Experience with descriptive summaries, inferential analyses, and derived endpoints is required.
• Solid understanding of one or more programming languages
• Solid attention to detail
• Comprehensive problem solving and innovative skills
• Solid written and verbal communications skills to effectively interface with teams and clients, including proficiency in the English language
• Capable of independently and effectively organizing and managing multiple assignments with challenging timelines
• Capable of adapting and adjusting to changing priorities
• Demonstrated positive attitude, enthusiasm toward work, and the ability to work well with others
• Demonstrated leadership, initiative and motivation
• Strong understanding of relational data base structure and complex data systems
• Capable of training and mentoring others
• Capable of effectively capturing biostatistical metrics
• Capable of providing quality control review for statistical programming.
• Must be legally authorized to work in the United States without sponsorship.
• Must be able to pass a comprehensive background check, which includes a drug screening.

Responsibilities

• Act as the lead statistician & programmer on selected studies of moderate complexity, working directly with project team leaders and client representatives to assess and develop project goals and timelines.
• Assume leadership responsibility as a contributing member of a multi-disciplinary clinical trials project team, communicating actively and frequently with other team members as needed.
• Independently create, execute, maintain, and validate programs that transfer data across multiple data management systems or operating systems, combine data from a variety of sources and structures, generate and store summary data from a variety of sources, generate reports or combine multiple databases and validate programs that generate listings, tables and figures using SAS.
• Manage and document assignments to meet timelines and deliver high quality work, being familiar with any relevant contractual obligations or limits.
• Increase knowledge base and professional skills in areas including programming, technology and techniques, clinical trials, and the pharmaceutical industry.
• Managing and analyzing large, complex, and diverse clinical datasets.
• Study design, statistical strategy, data standardization, analysis, and reporting.
• Conduct Statistical Programming and Validation of SDTM and ADaM datasets
• Generate Define.XML files for SDTM and ADaM datasets, and prepare the SDRG and ADRG
• Create annotated CRFs to map data collection fields to SDTM variables.
• Perform Statistical Analysis as outlined in the SAP.
• Compile TLFs for inclusion in the Final Clinical Study Report (FCSR)
• Comply with Quality Assurance and Compliance, following FDA CDISC standards and guidance.
• Generate Define.XML files for SDTM and ADaM datasets
• Prepare the Study Data Reviers’s Guide (SDRG) for SDTM datasets
• Prepare the Analysis Data Reviewer’s Guide (ADRG) for ADaM datasets
• Annotate the Case Report Form (CRF) to map data collection fields to SDTM variables
• Compile statistical analysis results and Tables, Listings and Figures (TLFs) into the FCSR for regulatory submission

Benefits

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs
• Employee assistance and family support programs, including commuter benefits and tuition reimbursement
• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
• Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level