Sr. Manager, Statistical Programming and Data Operations

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease. A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario. Summary: Manager, Statistical Programming and Data Operations (SPDO) in Biostatistics is responsible for vendor oversight and management to deliver the high-quality tables, listings, and figures (TLFs), as well as CDISC datasets for clinical trials and integrated statistical analysis intended for regulatory submissions, interfacing with cross-regional staffs in establishing and maintaining global data standards and department procedures. Essential Functions: Vendor Oversight and Management

• Responsible for developing TLF shells, CDISC deliverables, and TLFs in collaboration with stat/programming vendors.
• Participate in vendor selection/oversight processes: Create and/or review Requests for Proposal (RFP); track the progress of stat/programming activities and the project budget for stat/programming vendor; and manage the timeline of stat/programming deliverables.
• Collaborate with stat/programming vendors to ensure all statistical deliverables from the vendor meet timelines with quality. Oversee all aspects of statistical programming tasks performed by the vendor.
• Manage the stat/programming related TMFs in collaboration with stat/programming vendors and act as a subject matter expert at FDA inspections.

Internal Collaboration

• Interface with in-house staff: Participate on project team meetings; and manage the cost and timeline of stat/programming activities in collaboration with each project manager.
• Review protocols, case report forms, statistical analysis plans, specifications for raw data, clinical study reports, and the other study-related documents.
• Collaborate with biostatistician to provide statistical programming input on project topics and issues.

Statistical Programming

• Responsible for preparation of CDISC data submission package and SAS programming for regulatory documents (e.g. Response to information requests from HA; Integrated summaries; BIMO; and DSUR).
• Provide statistical programming for publications and presentations, ad-hoc and post-hoc analyses of clinical study data.
• Conduct programming QC reviews of vendor deliverables in accordance with internal guidelines and work instructions.
• Support departmental initiatives related to process building/improvement of programming activities.
• Coordinate and liaise with our Japanese colleagues, as needed, regarding global procedures, processes, and standards.

Requirements: Education Bachelor’s Degree or higher in Computer Science, Statistics, or closely related discipline. Experience

• Proven experience in statistical programming for clinical trials in the life sciences industry: six or more years with a Master’s degree, or eight or more years with a Bachelor’s degree.
• Experience in study oversight of statistical analysis for clinical trials in the life science industry
• Demonstrated expertise in CDISC standards and CDISC compliant submission requirements.
• Experience in data integration for ISS/ISE across multiple studies for regulatory submissions (preferred)
• Experience in using SAS-LSAF (i.e. Life Science Analytics Framework), including its repository and programming environment (preferred)

Technical Skills

• Excellent proficiency in SAS (required); Advance skill in R (preferred).
• Highly skilled in Microsoft Office applications (Word, PowerPoint, Excel, Outlook).
• Familiarity with ICH guidelines (especially E9) and other regulatory guidance.
• Solid understanding of development, regulatory and commercial aspects of drug development.

The anticipated salary for this position will be $145,000 to $160,000. The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs. The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including: 401K with company match Annual Bonus Program (Sales Bonus for Sales Jobs) Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision) HSA & FSA Programs Well-Being and Work/Life Programs Life & Disability Insurance Concierge Services Long Term Incentive Program (subject to job level and performance) Pet Insurance Tuition Assistance Employee Referral Awards The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market. KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law. When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing View email address on click.appcast.io. Controller’s data protection officer can be contacted at View email address on click.appcast.io. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment. Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union. Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment. Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at View email address on click.appcast.io. Recruitment & Staffing Agencies Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes. #Hybrid #Princeton