Sr. Scientist, Stat. Programming - SDTM (Hybrid)
Not Disclosed•Full-TimeOn-site
location_on1192, Knapp Road, Montgomery Township, Montgomery County, Pennsylvania, 19454, United States
About the Team
BARDS (Biostatistics and Research Decision Sciences) is a distinguished department within our renowned Research and Development division. Our quantitative scientists partner with subject matter experts to apply state-of-the-art scientific methodologies and tools. Our mission is to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for the benefit of patients and global human health.
About the Role
The Senior Statistical Programmer, Submission Data Standards Quality Management (SDSQM), serves as a key collaborator across statistical programming, statistics, regulatory, and project stakeholders. This role provides oversight and quality management for submission data standard deliverables used in worldwide regulatory application submissions for drug and vaccine clinical development projects.
You will drive the continuous improvement of our electronic submission process, focusing on traceability, quality assurance, data conformance, and data fitness. Your day-to-day involves coaching project teams, consulting on submission data standards planning, and managing outreach to external vendors and partners. You will ensure compliance with industry standards such as SDTM, ADaM, and Define.XML while preparing for FDA, EMA, and PMDA meetings. Additionally, you will guide teams in using tools like Pinnacle 21 Enterprise and participate in industry teams to stay current on best practices.
Hiring Process
Current employees can apply via the Workday Jobs Hub. Contingent workers should apply through the specific contingent worker portal. For US and Puerto Rico residents requiring an accommodation during the application or hiring process, please click the provided link to request support.
Culture & Equal Opportunity
We are proud to be a company that embraces the value of bringing together talented, committed people with diverse experiences, perspectives, skills, and backgrounds. We believe the fastest way to breakthrough innovation is when people with diverse ideas come together in an inclusive environment. We encourage colleagues to respectfully challenge one another's thinking and approach problems collectively.
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment. We prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.
We also consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance and the Los Angeles Fair Chance Initiative for Hiring Ordinance.
Work location
Work model: On-site
1192, Knapp Road, Montgomery Township, Montgomery County, Pennsylvania, 19454, United States
Montgomery Township, Pennsylvania
Key Responsibilities
- check_circleLead submission data standards planning activities and coach project teams on compliance
- check_circleManage outreach to external vendors and partners to ensure data conformance and fitness
- check_circlePrepare for PreNDA and PreBLA meetings and attend regulatory agency meetings with FDA, EMA, and PMDA
- check_circleProvide oversight and quality management of submission data standard deliverables for global regulatory applications
- check_circleGuide project teams in preparing submission deliverables using Pinnacle 21 Enterprise
- check_circleExecute up-versioning activities to specific versions of SDTM standards
- check_circleDrive continuous improvement of electronic submission processes and develop supporting tools and templates
- check_circleParticipate in industry teams and conferences to stay current on submission data standards and best practices
Requirements
- verifiedBA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 5 years SAS programming experience in a clinical trial environment
- verifiedMS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 3 years SAS programming experience in a clinical trial environment
- verifiedUS and/or worldwide drug or vaccine regulatory application submission experience
- verifiedExperience with submission standards CDISC (SDTM, ADaM), Define.XML, cSDRG, ADRG
- verifiedFamiliarity with clinical data management concepts
- verifiedVISA Sponsorship: Yes
Nice to Have
Hands-on experience with R and Python for data analysis and statistical modeling; Strong working knowledge of reporting processes (SOPs) and software development life-cycle (SDLC); Experience assuring consistency across protocols and projects; Ability and interest to work across cultures and geographies; Ability to complete statistical programming deliverables through the use of global outsource partner programming staff; Experience developing and managing a project plan using Microsoft Project or similar package; Active in professional societies; Experience in process improvement.
Benefits & Perks
check_circleMedical, dental, and vision healthcare insurance for employee and familycheck_circle401(k) retirement benefitscheck_circlePaid holidays, vacation, compassionate days, and sick dayscheck_circleEligibility for annual bonus and long-term incentive
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Frequently asked questions about Sr. Scientist, Stat. Programming - SDTM (Hybrid) at Wisconsin Department of Children and Families
What does a Sr. Scientist, Stat. Programming - SDTM (Hybrid) at Wisconsin Department of Children and Families do?expand_more
Day-to-day, the Sr. Scientist, Stat. Programming - SDTM (Hybrid) at Wisconsin Department of Children and Families will lead submission data standards planning activities and coach project teams on compliance; manage outreach to external vendors and partners to ensure data conformance and fitness; prepare for prenda and prebla meetings and attend regulatory agency meetings with fda, ema, and pmda; and provide oversight and quality management of submission data standard deliverables for global regulatory applications.
What are the requirements for this Sr. Scientist, Stat. Programming - SDTM (Hybrid) role?expand_more
Wisconsin Department of Children and Families is looking for candidates who meet the following requirements: BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 5 years SAS programming experience in a clinical trial environment; MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 3 years SAS programming experience in a clinical trial environment; US and/or worldwide drug or vaccine regulatory application submission experience; Experience with submission standards CDISC (SDTM, ADaM), Define.XML, cSDRG, ADRG; Familiarity with clinical data management concepts; and VISA Sponsorship: Yes.
Where is the Sr. Scientist, Stat. Programming - SDTM (Hybrid) role at Wisconsin Department of Children and Families located?expand_more
Sr. Scientist, Stat. Programming - SDTM (Hybrid) at Wisconsin Department of Children and Families is based in 1192, Knapp Road, Montgomery Township, Montgomery County, Pennsylvania, 19454, United States. This is a on-site role.
Is this Sr. Scientist, Stat. Programming - SDTM (Hybrid) job remote, hybrid, or on-site?expand_more
Wisconsin Department of Children and Families has listed this Sr. Scientist, Stat. Programming - SDTM (Hybrid) role as on-site.
How much experience is required for this Sr. Scientist, Stat. Programming - SDTM (Hybrid) role?expand_more
Sr. Scientist, Stat. Programming - SDTM (Hybrid) at Wisconsin Department of Children and Families typically requires 3+ years of relevant experience at the senior level.
What skills do you need for the Sr. Scientist, Stat. Programming - SDTM (Hybrid) role at Wisconsin Department of Children and Families?expand_more
Key skills for Sr. Scientist, Stat. Programming - SDTM (Hybrid) at Wisconsin Department of Children and Families include Sas Programming; Pinnacle 21 Enterprise; SDTM; Adam; Define.xml; CSDRG; Adrg; and R.
What category does the Sr. Scientist, Stat. Programming - SDTM (Hybrid) role belong to?expand_more
Sr. Scientist, Stat. Programming - SDTM (Hybrid) at Wisconsin Department of Children and Families is part of the scientific & qa job category on Recrutus.