Job Description

Responsibilities:

• Utilize big data to analyze the safety and efficacy claims of potential medical breakthroughs.

• Support statistical programming activities for Early Oncology clinical development projects.

• Review the quality and reliability of clinical studies using deep scientific knowledge, statistical analysis and high-quality data to support decision making in clinical trials.

• Responsible for the development and execution of statistical analysis and reporting deliverables (e.g., safety and efficacy analysis datasets, tables, listings, figures) for early oncology studies.

• Responsible for design and maintenance of statistical datasets that support multiple stakeholder groups, including clinical development and safety evaluation.

• Collaborate with statistics and other project stakeholders in ensuring project plans are executed efficiently with timely and high-quality deliverables.

• Effective analysis and report programming development and validation, utilizing global and therapeutic area (TA) standards and following departmental standard operating procedures (SOPs) and good programming practice

• Maintain and manage a project plan including resource forecasting.

• Coordinate the activities of a global programming team that includes outsourced provider staff.

Requirements:

Minimum education required:

Master's degree or equivalent in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or a related field and 3 years of experience in the position offered or related occupation. We will also accept a Bachelor's degree or equivalent in Computer Science, Statistics, Applied Mathematics, Life Sciences, and 5 years of experience in the job offered or related occupation.

Required experience and skills:

The required 3 and 5 years of experience is with all of the following: SAS programming in a clinical trial environment including data steps, procedures, SAS/MACRO, and SAS/GRAPH; developing analysis and reporting deliverables for R&D projects (data, analyses, tables, graphics, listings); working with SAS systems and statistical databases; designing and developing complex programming algorithms; experience with analysis plans which describe the methodology to be programmed; applying statistical terminology and clinical data management concepts; CDISC SDTM and ADaM standards; ensuring process compliance and deliverable quality; and designing statistical databases with objective to optimize analysis and reporting and leverage departmental standards and industry best practices.

1 year of experience with oncology clinical programming support

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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 presence.This 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".

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Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here.

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

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Requisition ID:R330058