Senior Scientist, Statistical Programming Full-time

Regulatory Submission Data Standards Manager

Provide oversight and quality management of submission data standard deliverables for world-wide regulatory application submissions of drug and vaccine clinical development projects.

Be accountable for submission data standards planning activities, coaching and consulting with project teams, outreach to external vendors and partners, and keeping current with industry submission data standards including SDTM, ADaM, clinical site data for CDER inspection planning, etc.

Responsible for continuous improvement of the company's electronic submission process and providing tools and templates to support delivery focusing on traceability, quality assurance, data conformance and data fitness.

Act as a key collaborator with statistical programming, statistics, regulatory and other project stakeholders.

Responsible for PreNDA and PreBLA meeting preparation, study data standards plan, preparing questions for FDA edata mailboxes (CBER/CDER), attendance at meetings with regulatory agencies (FDA, EMA, PMDA).

Guide project teams preparing submission deliverables including use of Pinnacle 21 Enterprise.

Responsible for up-versioning activities to specific versions of SDTM.

Participate in industry teams and conferences on best practices.

Be a member of departmental strategic initiative project teams.

Must have a bachelor's degree (or US equivalent) in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 5 years SAS programming experience in a clinical trial environment OR a master's degree (or US equivalent) in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 3 years SAS programming experience in a clinical trial environment.

Experience in US and/or worldwide drug or vaccine regulatory application submission including the development of electronic submission deliverables.

Experience with submission standards CDISC (SDTM, ADaM), Define.XML, SDRG, ADRG also required.

Must possess demonstrated success in the assurance of deliverable quality and process compliance.

Excellence in technical writing and ability to convert complex ideas and information into simple readable form.

Solid project management skills.

Familiarity with clinical data management concepts.

Strategic thinking ability to turn strategy into tactical activities, and ability to anticipate stakeholder requirements.

Must also possess 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).

Must be a project leader; and possess ability to complete tasks independently at a project level.

Ability to collaborate with key stakeholders.

$140,150 -$180,500 per year

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within 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.