Associate Principal Scientist, Stat. Programming A&R Standards, Innovation (Hybrid)

Job Description

In BARDS (Biostatistics and Research Decision Sciences) a distinguished department within our companys 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:

This position supports the design development and delivery of efficient flexible and modular analysis and reporting and submission standards that can be used for drug and/or vaccine projects across all therapeutic to standard operating procedures and guidelines established by the department. Drives data structures which includes analysis and reporting data standards and submission standards and actively contributes to the departments strategic initiatives.

Primary Activities:

• Develop and validate global programming standards for ADaM datasets

• Develop and validate global programming standards for efficacy analysis and reporting

• Develop and validate global programming standards for safety analysis and reporting

• Design and develop complex programming algorithms

• Provide technical consultation and analytical support to statistical programmers and statisticians

• Represent our company on relevant industry initiatives including R Consortium TransCelerate PHUSE CDISC.

• Collaborate with key stakeholders partners in driving Analysis & Reporting standard programs using our companys standards processes

Education and Minimum Requirement:

• BA/BS in Computer Science Statistics Applied Mathematics Life Sciences Engineering or related field plus minimum of 9 years of SAS programming experience in a clinical trial environment

• MS in Computer Science Statistics Applied Mathematics Life Sciences Engineering or related field plus 7 or more years of SAS programming experience in a clinical trial environment

Department Required Skills and Experience:

• 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 listings figures)

• Strong project management skills; leadership at a program level; determines approach and ensures consistency and directs development of others when opportunities arise; ability to engage key stakeholders

Position Specific Required Skills and Experience:

• Significant expertise in SAS and clinical trial programming including data steps procedures SAS/MACRO SAS/GRAPH and familiarity with at least one other statistical computing software

• Knowledge and understanding of CDISC SDTM and ADaM standards

• Experience working with analytical research databases including various analysis datasets and procedures/packages

• Demonstrated understanding of statistics clinical trial and data management concepts as applied to drug/vaccine development

• Demonstrated understanding of statistics clinical trial and data management concepts as applied to drug/vaccine development

**Preferred Skills and Experience:

• Experience in developing flexible and efficient complex analysis and reporting standard SAS macros

• R Python and XML experience

• Experience with Linked data natural language processing

• Experience using SAS R in Unix/Linux environment

• Ability to comprehend analysis plans which may describe methodology to be programmed; understanding of statistical terminology and concepts; Implements statistical methods not currently available through commercial software packages

• Ability and interest to work across cultures and geographies

• Active in professional societies

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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.

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 all qualified applicants including those with criminal histories in a manner consistent with the requirements of applicable state and local laws including the City of Los Angeles Fair Chance Initiative for Hiring Ordinance

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