Associate Principal Scientist, Statistical Programming - System Development Study Data Tabulation Model (SDTM)

Job Description

In BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our company's 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

Primary Responsibilities:

• Develop and validate global programming standards and tools for the production of Study Data Tabulation Model (SDTM) datasets.

• Design and develop complex programming algorithms and user interfaces.

• Supporting project teams in creating SDTM deliverables for Analysis and Reporting activities and submission.

• Collaborating with project teams to prepare the Case Report Tabulation (CRT) submission deliverables including use of Pinnacle 21 Enterprise.

Education Minimum Requirements:

• BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field with a minimum of 9 years Statistical Analysis System (SAS) programming experience in a clinical trial environment.

• MS (preferred) in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field with a minimum of 7 years Statistical Analysis System (SAS) programming experience in a clinical trial environment.

Required Experience and Skills:

• Proven track record for leading a compound or indication.

• Out of the box thinker with experience in strategic initiatives, technology implementation, increasing programming efficiency, creating requirement documentation and understanding wider organizational objectives.

• Expertise in SAS for system development and clinical trial programming.

• Broad knowledge in developing analysis and reporting deliverables for Research & Development (R&D) projects (data, analyses, tables, graphics, listings).

• Clinical Data Interchange Standards Consortium (CDISC), Study Data Tabulation Model (SDTM), Define.XML, SDRG, aCRF; knowledge of Analysis Dataset Model (ADaM) and Analysis Data Reviewer’s Guide (ADRG) considered a plus.

• Excellent communication and interpersonal skills and ability to negotiate and partner effectively.

• Excellent written, oral, and presentation skills.

• Excels in technical writing, able to convert complex ideas and information into simple readable form.

• Strong project management skills; Manage at a program level; influences approach/s and ensures consistency and directs development of others when opportunities arise; ability to engage key stakeholders.

• Demonstrated success in the assurance of deliverable quality and process compliance.

• Familiarity with statistics and clinical data management concepts.

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Preferred Experience and Skills:

• Strong working knowledge of reporting processes Standard Operating Procedures (SOPs) and software development life-cycle (SDLC).

• Provide technical and/or programming guidance and mentoring to colleagues.

• Deals well with change and seamlessly assimilates to new projects and stakeholders.

• Ability to anticipate stakeholder requirements.

• Strategic thinking ability to turn strategy into tactical activities.

• Ability and interest to work across cultures and geographies.

• Ability to complete statistical programming deliverables through the use of global outsource partner programming staff.

• Develop and manage project plan using Microsoft Project or similar package.

• Active in industry forums and professional societies.

• Process improvement and familiarity with Meta Data Repositories.

• United States and/or worldwide drug or vaccine regulatory application submission experience at the leadership level including the development of CRT SDTM study data standard deliverables.

• Strong knowledge of study data standards.

• Up-versioning activities to specific versions of Statistical Analysis System (SDTM).

• Participation in industry teams and conferences on best practices.

• Membership on departmental strategic initiative project teams.

Keyword: SASPRO

BARDS2020

SPjobs

EBRG

eligibleforERP

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