Senior Manager, Statistical Programming
Otsuka Pharmaceutical Co., Ltd.
A complete application in a minute
Tailored resume and cover letter, ready to send.
Benefits offered by this job
Job summary
Otsuka Pharmaceutical Co., Ltd. seeks a Senior Statistical Programmer to lead development and validation of TFLs for clinical trials, collaborating across Statistical Programming, cross-functional teams, and external vendors.
Responsibilities include end-to-end programming for SDTM/ADaM, strategy development, and contributing to submissions with robust QA, AI-enabled programming, and regulatory-compliant outputs.
Qualifications
- Proficiency in SAS, R and AI-enabled programming to produce derived analysis datasets and TFLs.
- Knowledge of CDISC standards, relational databases and industry data standards.
- Experience with software tools (MS Office, XML, Pinnacle 21) and adopting AI-enabled tech in regulated environments.
- Ability to deliver outputs meeting submission requirements (ADaM datasets, define.xml, reviewer guides).
Responsibilities
- Lead end-to-end statistical programming activities for SDTM/ADaM and TFL content.
- Validate programming outputs for accuracy, reproducibility and regulatory readiness.
- Support project teams with programming strategies, standards, and AI-enabled approaches.
- Lead submission preparations, regulatory responses, and vendor interactions.
Skills
Education
Tools
Job description
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 with the Statistical Programming team, with cross‑functional teams, and external vendors.
- 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
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
Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
Make decisions considering the long‑term impact to customers, patients, employees, and the business.
Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals.
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.
This will be posted for a minimum of 5 business days.
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. Come discover more about Otsuka and our benefit offerings; https://ah-prod.com/multi/videoplayer/player.html?v=6385356920112.
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 EEAccommodations@otsuka-us.com.
Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre‑existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
'/%3e%3cpath%20d='M101.744%2012.4726L102.894%2016.1947L99.0021%2013.2201L101.744%2012.4726ZM105.3%208.40937H100.488L99.0026%203.59473L97.5116%208.41047L92.7%208.40385L96.5965%2011.3834L95.1055%2016.1942L99.0021%2013.2196L101.408%2011.3834L105.3%208.40992V8.40937Z'%20fill='white'/%3e%3cdefs%3e%3clinearGradient%20id='paint0_linear_5593_1381'%20x1='90'%20y1='9.44471'%20x2='99'%20y2='9.44471'%20gradientUnits='userSpaceOnUse'%3e%3cstop%20stop-color='%2300AD70'/%3e%3cstop%20offset='0.998594'%20stop-color='%2300B67A'/%3e%3cstop%20offset='1'%20stop-color='%23DCDCE6'/%3e%3c/linearGradient%3e%3c/defs%3e%3c/svg%3e){kind=small}
