Job Description
Responsibilities:
Responsible for leading and participating in the development and validation of datasets, tables, listings, and figures (TLFs) that support the analysis and reporting of clinical trials and for providing expertise for statistical programming activities. Develop collaborative relationships and work effectively within the Statistical Programming team, with cross-functional teams, and external vendors. Core responsibilities include:
- Create SAS programs to generate derived analysis datasets and content for TLFs.
- Perform programming validation to ensure quality of analysis datasets and programming outputs.
- Provide programming support for project teams, including development of programming strategies, standards, specifications, and programmed analysis.
- 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.
- Interact with vendors regarding project standards, programming conventions, programming specifications and file transfers.
- Provide leadership for 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 and consistency withing Statistical Programming, Clinical Analytics, and interactions with vendors.
- Independently lead and perform programming assignments with minimal supervision.
- Lead and/or participate in process improvement standards and automation initiatives.
- Collaborate with other function managers and Otsuka departments (i.e., Safety, Medical Writing, Clinical, Biostatistics and Quality Management) to ensure requirements are satisfactorily fulfilled.
- Develop Clinical Programming Group training manuals to promote standard processes and procedures.
- Supervise contract workers.
- Up to 10% domestic travel to client sites and professional meetings.
Requirements:
- Master’s degree or foreign equivalent in Statistics, Biostatistics, Mathematics, Data Analytics, Pharmacology, Computer Science, or related life sciences field.
- Four (4) years of experience with SAS programming, R, or other programming languages to produce derived analysis datasets and TFls.
- Four (4) years of experience using clinical data and regulatory submissions software tools and applications such as Pinnacle 21.
- Four (4) years of experience providing outputs to meet submission requirements such as ADaM datasets, define files, and reviewer’s guides.
- Four (4) years of experience with drug development process, clinical trials, statistical analysis plans and protocol designs.
- Four (4) years of experience with medical terminology, e.g., trial objectives, trial design, sample size, baseline measurement, analysis visit windowing, safety tables, and efficacy tables.
Apply to: [email protected]. Otsuka Pharmaceutical Development & Commercialization, Inc.
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.
Come discover more about Otsuka and our benefit offerings; https://www.otsuka-us.com/careers-join-otsuka.
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 Accommodation Request.
Statement Regarding Job Recruiting Fraud Scams
At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.
Please understand, Otsuka will never ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment.
Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters.
To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website https://vhr-otsuka.wd1.myworkdayjobs.com/en-US/External.
Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka’s call center at: 800-363-5670. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: https://www.ic3.gov, or your local authorities.
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.
Top Skills
What We Do
There are two Otsuka pharmaceutical industry companies in the U.S.:
Otsuka America Pharmaceutical, Inc. (OAPI) successfully commercializes Otsuka-discovered and in-licensed products in North America.
Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) clinically develops and registers innovative healthcare products on a global basis.
