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

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description 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 Qualification requirements: Education 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. Experience requirements 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.

Knowledge, Skills, Abilities:

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.

Location:

Office based with our client at Walter Reed Army Institute of Research, in Silver Spring, Maryland. •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. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued. Apply today!

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//jobs.thermofisher.com Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Accessibility/Disability Access Job Seekers with a

Disability:

Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255•. Please include your contact information and specific details about your required accommodation to support you during the job application process. •This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response. Compensation and Benefits The salary range estimated for this position based in Maryland is $112,000.00-$143,000.00. This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes: 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 For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards Thank you for your interest as you consider starting a new career journey with us. As the world leader in serving science, our colleagues develop critical solutions through innovation—and build rewarding careers. Discover their extraordinary stories and connection to our Mission to enable our customers to make the world healthier, cleaner and safer. Their work is a story of purpose. What story will you tell? Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.