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

Job Description

In BARDS (Biostatistics and Research Decision Sciences) a distinguished department within 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 enable 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 oversight 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 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.

The incumbent will be responsible for continuous 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 related field plus 5-9 years SAS programming experience in a clinical trial environment

• MS in Computer Science Statistics Applied Mathematics Life Sciences Engineering or related field plus 3-7 years SAS 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 ).

• 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 complex ideas 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 SAS 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 Microsoft Project or similar tools

• Active participation in professional societies

• Experience leading or contributing to process improvement initiatives

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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 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

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 employees 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. More information about benefits is available at can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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