![Kyowa Kirin](https://www.energyjobline.com/sites/default/files/styles/squared_logo/public/job-logo/get-logo.php__16466.png?itok=jEhkx9YY)
Senior Manager, Pharmaceutical Statistical Programming and Data Operations
4 weeks ago
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 make people smile by delivering breakthroughs 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, Massachusetts, and Ontario.
Summary:
Senior 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
Master's Degree in Computer Science, Statistics, or closely related discipline.
Experience
· Minimum eight (8) years' experience in statistical programming for clinical trials in the life science industry.
· Demonstrated expertise in CDISC standards and CDISC compliant submission requirements.
· Must have experience in data integration for ISS/ISE across multiple studies for regulatory submissions.
· Experience in using SAS-LSAF (i.e. Life Science Analytics Framework), including its repository and programming environment (preferred)
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 Controller's data protection officer can be contacted at 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
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.
#LI-TT1 #Hybrid
-
Associate Director, Statistical Programming
1 month ago
Princeton, New Jersey, United States Bristol Myers Squibb Full timeWorking with UsChallenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the...
-
Senior Financial Operations Manager
7 days ago
Princeton, New Jersey, United States Precision Life Sciences Full timeJob Description: Senior Financial Operations ManagerPurpose:We are looking for an outstanding Senior Financial Operations Manager to establish risk-based governance frameworks to manage intricate and distinctive business activities and challenges. This position will be pivotal in leading benchmarking and process enhancement initiatives aimed at strengthening...
-
Head of Biostatistics
4 days ago
Princeton, New Jersey, United States PMV Pharmaceuticals, Inc. Full timeDirector of Biostatistics & Data AnalyticsPMV Pharmaceuticals is at the forefront of developing innovative p53 reactivators aimed at combating cancer. By leveraging over thirty years of expertise in p53 biology, PMV Pharmaceuticals merges deep biological insights with a strong focus on pharmaceutical development.The organization is seeking a qualified...
-
Director, Statistical Methodology
1 month ago
Princeton, New Jersey, United States Bristol Myers Squibb Full timeWorking with UsChallenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the...
-
Director, Statistical Methodology
2 weeks ago
Princeton, New Jersey, United States Bristol Myers Squibb Company Full timeWorking with UsChallenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the...
-
Head of Biostatistics
6 days ago
Princeton, New Jersey, United States PMV Pharmaceuticals, Inc. Full timeDirector, Biostatistics & Data AnalyticsPMV Pharmaceuticals, Inc. is at the forefront of developing innovative p53 reactivators aimed at treating cancer. Our team comprises experts in the field, leveraging over thirty years of p53 biological research to merge scientific insights with a strong focus on pharmaceutical development.We are seeking a qualified...
-
Senior Clinical Research Specialist
2 days ago
Princeton, New Jersey, United States Global Pharmaceutical Company Full timePosition Overview:We are seeking a Senior Clinical Research Specialist to join our dynamic team at a leading Global Pharmaceutical Company. This role is integral to our Center for Outcomes Research, Real-world Evidence, and Epidemiology (CORE) team within Global Medical Affairs.Contract Details:This is a long-term contract opportunity with the potential for...
-
Senior Clinical Research Specialist
7 days ago
Princeton, New Jersey, United States GLOBAL PHARMACEUTICAL CORPORATION Full timePosition Overview: The Senior Clinical Research Scientist plays a pivotal role within the Global Medical Affairs team, specifically supporting the Center for Outcomes Research, Real-world Evidence, and Epidemiology (CORE). This position is essential for driving the scientific understanding of product value and effectiveness in the healthcare landscape. Key...
-
Senior Vice President, Access Strategy
7 days ago
Princeton, New Jersey, United States Sun Pharmaceutical Industries, Inc. Full timePosition Title:Head of Market AccessLocation:Princeton, NJReporting Relationship:CCOEmployment Duration:Full timeSun Pharmaceutical Industries Ltd. (Sun Pharma) stands as the fourth largest specialty generic pharmaceutical enterprise globally, boasting revenues exceeding $4.5 billion US Dollars. With a robust network of over 40 manufacturing facilities, we...
-
Senior Vice President of Market Access
7 days ago
Princeton, New Jersey, United States Sun Pharmaceutical Industries, Inc. Full timePosition Title:Head of Market AccessLocation:Princeton, NJReporting Relationship:CCOEmployment Duration:Full timeSun Pharmaceutical Industries Ltd. (Sun Pharma) stands as a leading specialty generic pharmaceutical entity globally, boasting revenues exceeding $4.5 billion. With over 40 manufacturing sites, we deliver high-quality, affordable medications,...
-
Senior Vice President of Market Access
7 days ago
Princeton, New Jersey, United States Sun Pharmaceutical Industries, Inc. Full timePosition Title:Head of Market AccessLocation:Princeton, NJReporting Relationship:CCOEmployment Duration:Full timeSun Pharmaceutical Industries Ltd. (Sun Pharma) stands as a leading specialty generic pharmaceutical firm globally, boasting revenues exceeding $4.5 billion. With over 40 manufacturing sites, we deliver high-quality, affordable medications,...
-
Head of Biostatistical Research
7 days ago
Princeton, New Jersey, United States PMV Pharmaceuticals, Inc. Full timeLead Biostatistician in Oncology ResearchBecome a vital part of our forward-thinking team at PMV Pharmaceuticals, Inc., a leader in the development of innovative p53 reactivators aimed at revolutionizing cancer treatment. Our commitment to integrating biological insights with pharmaceutical advancements positions us at the cutting edge of cancer therapy.We...
-
Sr. Manager, Biostatistician
3 weeks ago
Princeton, New Jersey, United States Kyowa Kirin Full timeKyowa 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 make people smile by delivering breakthroughs where no...
-
Senior Marketing Manager, US Operations
7 days ago
Princeton, New Jersey, United States Ascendis Pharma Full timeSenior Marketing Manager, US Operations at Ascendis PharmaAscendis Pharma is a leading global biopharmaceutical organization specializing in Endocrinology, Rare Diseases, and Oncology. We are in search of a skilled Senior Marketing Manager to join our US Operations team, responsible for spearheading marketing strategies for our innovative treatment targeting...
-
Senior Vice President, Access Strategy
6 days ago
Princeton, New Jersey, United States Sun Pharmaceutical Industries, Inc. Full timePosition Title:Head of Market AccessLocation:Princeton, NJReporting Relationship:CCOEmployment Duration:Full timeSun Pharmaceutical Industries Ltd. (Sun Pharma) stands as the fourth largest specialty generic pharmaceutical enterprise globally, boasting revenues exceeding $4.5 billion US Dollars. With a robust network of over 40 manufacturing facilities, we...
-
Pharmaceutical Sales Representative
7 days ago
Princeton, New Jersey, United States Kaléo Full timeKalo is a pioneering pharmaceutical organization focused on developing innovative solutions for serious and life-threatening medical conditions. Founded by patients, we prioritize their needs and experiences in everything we do.Unlike traditional pharmaceutical companies, Kalo is a dynamic team of passionate individuals who inspire each other to think...
-
Senior Manager of Commercial Forecasting
7 days ago
Princeton, New Jersey, United States Bristol-Myers Squibb Full timeBristol Myers Squibb is a prominent pharmaceutical organization committed to enhancing patients' lives through innovative research and a diverse product pipeline. The company is seeking a Senior Manager / Associate Director of US Forecasting to become a vital part of their Commercial Performance & Forecasting division. This position entails working closely...
-
Senior Manager of Commercial Forecasting
7 days ago
Princeton, New Jersey, United States Bristol-Myers Squibb Full timeBristol Myers Squibb is a prominent pharmaceutical organization focused on enhancing patient outcomes through groundbreaking science and a varied product pipeline. The company is currently seeking a Senior Manager / Associate Director of US Forecasting to be part of their Commercial Performance & Forecasting division. This position entails working closely...
-
Senior Clinical Research Specialist
7 days ago
Princeton, New Jersey, United States GLOBAL PHARMACEUTICAL CORPORATION Full timePosition Overview: The Senior Clinical Research Specialist plays a pivotal role within the Global Medical Affairs team, specifically supporting the Center for Outcomes Research, Real-world Evidence, and Epidemiology (CORE). This position is integral to the US CORE team. Contract Details: This is a long-term contract role with the potential for permanent...
-
Senior Manager of Commercial Analytics
7 days ago
Princeton, New Jersey, United States Bristol-Myers Squibb Full timeBristol Myers Squibb is a prominent pharmaceutical organization committed to enhancing patients' lives through groundbreaking science and a varied product pipeline. The company is seeking a Senior Manager / Associate Director of US Forecasting to be part of their Commercial Performance & Forecasting division. This position entails close collaboration with...