Senior Manager, Statistical Programming

Otsuka America Pharmaceutical Inc.; Boise (ID); Remote; USD 150,000 - 224,000; Full time

Benefits offered by this job

Medical, dental, vision

401(k) match

Paid time off

Tuition reimbursement

Job summary

Otsuka America Pharmaceutical Inc. is seeking a Senior Manager, Statistical Programming to lead development and validation of TFLs for clinical trials.

The role emphasizes collaboration within the Statistical Programming team, cross-functional teams, and external vendors to ensure data integrity and regulatory compliance. The position involves leading programming strategies, quality reviews, AI-enabled approaches, and submission support, with a focus on SDTM/ADaM and regulatory deliverables in a

Qualifications

• Proficiency in SAS, R and AI-enabled programming tools for TFLs
• Knowledge of CDISC standards and data structures
• Experience with ADaM/SDTM, define.xml and regulatory deliverables
• Ability to develop programming strategies and standards
• Experience with AI-enabled programming in regulated environments
• Master's degree with 4+ years in pharma is preferred

Responsibilities

• Lead end-to-end statistical programming activities for TFLs
• Develop and validate datasets and listings for trials
• Review and align planning documents with programming deliverables
• Support submission preparations and regulatory responses
• Interact with vendors on standards and AI-enabled workflows
• Lead process improvements and automation initiatives
• Supervise contract workers and guide programming practices

Skills

SAS

R

AI-enabled programming tools

CDISC standards

Programming validation

Education

Master's degree in Statistics/ Biostatistics/ Mathematics/ CS/ Life Sciences

Tools

Pinnacle 21

XML

MS Office

Job description

Remote

Full time

R13003

Job Summary

The Senior Manager, Statistical Programming is responsible for leading and participating in the development and validation of datasets, tables, figures, and listings (TFLs) that support the analysis and reporting of clinical trials and for providing expertise for statistical programming activities. This role will be expected to develop collaborative relationships and work effectively within the Statistical Programming team, with cross-functional teams, and external vendors.

Job Description

• Create SAS programs and AI-assisted programming solutions to perform end-to-end statistical programming activities including SDTM, ADaM, and content for TFLs
• Perform programming validation and quality review to ensure the accuracy, reproducibility, and integrity of analysis datasets, programming outputs, and AI-generated deliverables
• Provide programming support for project teams, including development of programming strategies, standards, specifications, programmed analyses, and AI-enabled programming approaches
• Lead and/or support submission preparations, deliverables, and regulatory responses
• Review key planning documents (e.g., statistical analysis plan, data presentation plan, data review plan) to ensure alignment with development team objectives and clarity and completeness of programming assumptions and requirements; assess impact on programming activities
• Develop or review validation plans for programming deliverables to ensure quality and consistency of outputs
• Interact with vendors regarding project standards, programming conventions, programming specifications, file transfers, and AI-enabled programming practices, as applicable
• Provide leadership in ensuring quality of deliverables by consistently applying standards and complying with regulatory requirements, guidance, and corporate and departmental SOPs and working practices.
• Identify opportunities for increased efficiency, consistency, automation, and quality within Statistical Programming and interactions with vendors through innovative programming approaches and appropriate use of AI-enabled technologies
• Independently lead and perform programming assignments with minimal supervision
• Lead and/or participate in process improvement, standards, automation, and AI adoption initiatives that enhance productivity, quality, scalability, and consistency across Statistical Programming
• Supervise contract workers and provide guidance on programming standards, quality expectations, and effective use of AI-enabled programming tools and workflows
• Evaluate, implement, and champion emerging AI-enabled programming capabilities to streamline workflows, accelerate deliverable development, and drive continuous improvement while maintaining appropriate quality, traceability, and regulatory controls

Qualifications/ Required

Knowledge/ Experience and Skills:

• Demonstrate proficiency in using SAS, R (preferrable), and AI-enabled programming tools to produce derived analysis datasets and TFLs
• Knowledge of CDISC standards, relational database structures, and industry data standards.
• Experience using software tools and applications (e.g., MS Office, XML, Pinnacle 21) and the ability to effectively adopt and apply emerging AI-enabled technologies
• Ability to provide outputs that meet submission requirements, including ADaM datasets, define.xml files, reviewer guides, and other regulatory deliverables
• Strong knowledge of regulatory, industry, and technology standards and requirements, including the appropriate use of AI-enabled tools in regulated environments
• Good knowledge of the drug development process, clinical trials, medical terminology, statistical analysis plans, and protocol designs
• Ability to work effectively in a team environment with clinical team members, vendors, and cross-functional stakeholders
• Demonstrated ability to identify opportunities to improve productivity, quality, consistency, and automation through innovative programming approaches and AI-enabled solutions
• Ability to critically evaluate, validate, and oversee AI-generated outputs to ensure accuracy, reproducibility, traceability, and compliance with established standards and procedures
• Ability to support and influence the adoption of new technologies, standards, and AI-enabled programming practices across project teams
• Experience supporting rare disease therapeutic areas and/or PK/PD analyses, preferred but not required
• Master's degree in Statistics, Biostatistics, Mathematics, Computer Science, Life Sciences, or equivalent preferred, with at least 4 years of pharmaceutical industry experience preferred

Competencies

Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.

Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business.

Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders.

Impactful Communication - Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.

Respectful Collaboration - Seek and value others’ perspectives and strive for diverse partnerships to enhance work toward common goals.

Empowered Development - Play an active role in professional development as a business imperative.

Minimum $150,034.00 - Maximum $224,250.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate’s job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.

Application Deadline : This will be posted for a minimum of 5 business days.

Company benefits: Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.

Disclaimer:

This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.

Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.

If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting [e-mail].

Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the corporate philosophy: Otsuka people creating new products for better health worldwide. In the U.S., Otsuka is comprised of two companies, Otsuka America Pharmaceutical, Inc., and Otsuka Pharmaceutical Development & Commercialization, Inc., that share a deep commitment to the development and commercialization of innovative products in the spaces of neuroscience, nephrology, and digital medicine.

Driven by our purpose to defy limitation, so that others can too, we have an unwavering belief in doing more and transcending expectations. In going above and beyond - under any circumstances - for patients, families, providers, and for each other. It’s this deep-rooted dedication that drives us to uncover answers to complex, underserved medical needs, so that patients can push past the limitations of their disease and achieve more than they thought was possible each and every day.

OPDC and OAPI are indirect subsidiaries of Otsuka Pharmaceutical Company, Ltd., which is a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan. The Otsuka group of companies employed 34,400 people worldwide and had consolidated sales of approximately USD 14.2 billion in 2023.

We invite you to explore our open positions for an opportunity to join our 2,200 colleagues in the U.S. whose passion for our mission and pride in our company have earned us certification as a Great Place to Work by the Great Place to Work Institute.