Statistical Programming - Analysis & Reporting Programming and Systems (Hybrid)
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.
This position supports the centralized management of technology, platforms, inspections, and related process and training for the global Statistical Programming organization. The individual supports the organization to ensure it operates in compliance with departmental and company SOPs, regulatory requirements, and standards.
Development and maintenance SOPs, corresponding processes, assuring they are of high quality and compliant with regulatory requirements
Applies "Quality by Design" (QBD) principles to all BARDS processes and projects
Development and maintenance of training content, including videos
Business System Ownership of platforms or applications and corresponding documents and training
Drive compliance initiatives, change management and communication
Partnership in managing, prioritizing, and implementing portfolio projects
Supports audit and inspections Center of Excellence with audits, inspections and CAPA (Corrective Action and Preventive Action) management
Engagement with operational staff and partners globally
Lead and actively contribute to departmental strategic initiative project teams
Additional responsibilities as delegated by Manager
Education and Minimum Requirement:
BA/BS in Computer Science, Statistics, Applied Mathematics, Pharmacy, Nursing, Information Technology, Life Sciences, Engineering, or related field plus 5-8 years in a clinical trial environment (Analysis & Reporting, Information Technology, Data Management etc.) in the pharmaceutical industry, and 3-5 years SAS or R programming experience.
MS in Computer Science, Statistics, Applied Mathematics, Pharmacy, Nursing, Information Technology, Life Sciences, Engineering, or related field plus 2-5 years in a clinical trial environment (Analysis & Reporting, Information Technology, Data Management etc.) in the pharmaceutical industry, and 3-5 years SAS or R programming experience.
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:
Comprehensive knowledge of reporting processes (SOPs) that align with regulatory requirements (e.g., 21 CFR Part 11, ICH GCPs) and software development life cycle (SDLC)
Understanding of Statistical, Clinical, Medical Monitoring and Data Management concepts as applied to drug/vaccine development within the pharmaceutical industry.
Broad knowledge of clinical trials processes, data structures and corresponding tools used to manage, extract, analyze & report data.
Demonstrated success in the assurance of deliverable quality and process compliance.
Ability to anticipate stakeholder requirements; focus on customers; ability to listen to and address stakeholders’ needs and concerns.
Ability and interest to work across cultures and geographies including partnering with statistical programming staff in AP and EU regions and offshore programming resources.
Demonstrated ability to communicate effectively across multiple audiences and clearly explain processes and system functionality to users.
Exceptional people and thought leadership skills, with the ability to think strategically, work independently and influence others.
SAS or R programming experience
** Preferred Skills and Experience:
Experience developing and maintaining process documents e.g., SOPs.
Experience developing and maintaining training content, including videos.
Experience in process assessment, improvement, and operational excellence
Experience developing and managing a project plan.
Experience with SDLC, ALM, SAS, R, Jira, Confluence, Agile, Digital SDLC
Active in professional societies.
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.
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U.S. Hybrid Work Model
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, generally Tuesday, Wednesday and either Monday or 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”.
Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.
Expected salary range:$107,600.00 - $169,400.00
Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here.
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Flexible Work Arrangements:Hybrid
Shift:1st - Day
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