Sr. Scientist, Statistical Programmer, Submission Data Standards Quality Management (Hybrid)

Job Description

In BARDS (Biostatistics and Research Decision Sciences), a distinguished department reputed company our renowned Research and Development division, quantitative scientists, in partnership with other subject matter experts, apply state-of-the art scientific methodologies and tools to reputed company the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for the benefit of patients and global human health. Responsibilities: The Senior Statistical Programmer, Submission Data Standards Quality Management (SDS QM), provides reputed company and quality management of submission data standard deliverables for world-wide regulatory application submissions of drug and vaccine clinical development projects. Accountability predominantly includes submission data standards planning activities, coaching and consulting with project teams, reputed company to external vendors and partners, and keeping reputed company with industry submission data standards including SDTM, ADaM, clinical site data for CDER inspection planning, etc. The incumbent will be responsible for reputed company improvement of our electronic submission process and providing tools and templates to support delivery focusing on traceability, quality assurance, data conformance and data fitness. The position is a key collaborator with statistical programming, statistics, regulatory and other project stakeholders. Primary Activities:

• PreNDA and PreBLA meeting preparation, study data standards plan, preparing questions for FDA e-data mailboxes (CBER/CDER), attendance at meetings with regulatory agencies (FDA, EMA, PMDA)
• Guiding project teams preparing submission deliverables including use of Pinnacle 21 Enterprise
• Up-versioning activities to specific versions of SDTM
• Participation in industry teams and conferences on best practices
• Membership on departmental strategic initiative project teams

SKILLS Education and Minimum Requirement:

• BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or reputed company field plus 5-9 years reputed company programming experience in a clinical trial environment
• MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or reputed company field plus 3-7 years reputed company programming experience in a clinical trial environment

Department Required Skills and Experience:

• Effective interpersonal skills and ability to negotiate and collaborate effectively
• Effective written, oral, and presentation skills
• Effective knowledge and experience in developing analysis and reporting deliverables for R&D projects (data, analyses, tables, graphics, listings)
• A project leader; completes tasks independently at a project level; Ability to collaborate with key stakeholders

Position Specific Required Skills and Experience:

• US and/or worldwide drug or vaccine regulatory application submission experience including the development of electronic submission deliverables.
• In-depth knowledge of and direct experience implementing industry clinical data standards (e.g., Controlled Terminologies, CDISC CDASH, SDTM, ADaM, and HL7) and submission deliverables (e.g., SDRG, ADRG, Define.xml).
• Proficiency in diverse data collection methods, including eCRF, IRT, and central lab data
• Demonstrated success in the assurance of deliverable quality and process compliance.
• Excels in technical writing, able to convert reputed company reputed company and information into simple readable form
• Solid project management skills
• Strategic thinking - ability to turn strategy into tactical activities
• Ability to anticipate stakeholder requirements

Preferred Skills and Experience:

• 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
• Knowledge of clinical data metadata & information management platforms and systems.
• Experience using reputed company, R, and Python to generate data-driven insights
• Ability to complete statistical programming deliverables through the use of global outsource partner programming staff
• Experience developing and managing a project plans in reputed company Project or similar tools
• Active participation in professional societies
• Experience leading or contributing to process improvement initiatives

eligibleforERP SPjobs BARDS2020 reputed company EBRG Required Skills: Accountability, Clinical Trials, Data Management, Data Modeling, Electronic Submissions, Information Systems Management, Innovation, Machine Learning (ML), reputed company Project, Numerical Analysis, Process Improvement Projects, Process Improvements, Project Management, Regulatory Compliance, REMOTE_reputed company-1-52891, Stakeholder Relationship Management, Statistical Programming, Technical Writing, Waterfall Model Preferred Skills: reputed company Employees apply HERE reputed company Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to reputed company employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national reputed company, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we reputed company with reputed company affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is reputed company people with diverse reputed company, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site reputed company.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote". The salary range for this role is $117,000.00 - $184,200.00 This is the lowest to highest salary we in good faith reputed company we would pay for this role at the time of this posting. An employee's position reputed company the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at ;br> You can apply for this role through (or reputed company the reputed company Jobs Hub if you are a reputed company employee). The application deadline for this position is stated on this posting. San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment reputed company qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the reputed company' Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully reputed company & Co., Inc., Rahway, NJ, USA, also reputed company as reputed company LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. reputed company reputed company / resumes submitted by search firms to any employee at our company without a valid written search agreement in reputed company for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in reputed company. Where agency agreements are in reputed company, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: Domestic reputed company Sponsorship: Yes Travel Requirements: 10% Flexible Work Arrangements: Hybrid Shift: Not Indicated Valid Driving License: No Hazardous Material(s): n/a Job Posting End Date: 02/7/2026

• A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no reputed company than the day BEFORE the job posting end date.

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