Associate Principal Scientist, Statistical Programming

Job Description

Primary Activities:

• Provide high quality statistical programming analysis and reporting deliverables for global stakeholders in Early Development Statistics and global PK/PD modeling and simulation stakeholders spanning all therapeutic areas except oncology.

• Gather and interpret user requirements for analysis and programming requests in close collaboration with stakeholders (statisticians/modelers) and clinical colleagues, retrieve the required data, transform the data into analysis/modeling datasets, and develop tables and figures according to statistical/modeling analysis plan.

• Partner with stakeholders to solve problems; reduce the amount of programming task being completed by stakeholders to facilitate an increase in efficiency and compliance for statistical/modeling analyses.

• Write programs to analyze data with statistical methods which are not currently available through commercial software packages.

• Act as a key collaborator with statisticians, modelers, and colleagues in other related function areas.

• Pre-process, filter, and manipulate complex data for the analyses of molecular biomarker data, imaging data, and external data other than traditional laboratory data.

• Provide technical consultation and analytical support to early development statisticians for exploratory and unplanned statistical analyses.

• Prepare compliant programming code for regulatory submissions including analysis/modeling datasets, tables, listings, figures and associated documentation.

• Ensure programmatic traceability from data source to analysis/modeling result.

• Maintain and manage a project plan including resource forecasting.

• Support the development of programming standards to enable efficient and high-quality production of programming deliverables.

• Represent statistical programming on process improvement activities.

Required Education:

• Must have a Master’s degree in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus at least 7 years SAS programming experience in a clinical trial environment OR a Bachelor’s degree in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 9 years SAS programming experience in a clinical trial environment.

Required Skills and Experience:

• Experience in CDISC SDTM and ADaM standards is also required.

• Must possess significant expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH and programming expertise with clinical endpoint data (efficacy and safety) and pharmacokinetic data (raw concentration data, derived PK parameters).

• Ability to design and develop complex programming algorithms; ability to comprehend analysis plans which may describe methodology to be programmed; understanding of statistical terminology and concepts; and ability to implement statistical methods not currently available through commercial software packages required.

• Must have demonstrated success in the assurance of deliverable quality and process compliance and possess ability to thrive in an exploratory environment, handling non-standard data in a variety of formats with minimal requirements; knowledge of pharmaceutical development processes; and ability to efficiently manipulate very large databases including complex data preprocessing, filtering, and manipulation.

• Must possess strategic thinking with ability to turn strategy into tactical activities; ability to design statistical databases with the end in mind that optimize analysis and reporting and leverage departmental standards and industry best-practices.

• Must possess excellent interpersonal skills and ability to negotiate and collaborate effectively; excellent written, oral, and presentation skills; broad knowledge and significant experience in developing analysis and reporting deliverables for R&D projects (data, analyses, tables, graphics, listings); and strong project management skills; leadership at a program level; ability to determine approach and ensure consistency and directs development of others when opportunities arise; ability to engage key stakeholders.

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