Senior Manager, Statistical Programming (Hybrid)
The Senior Manager, Statistical Programming leads and participates 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. You will develop collaborative relationships and work within the Statistical Programming team, with cross-functional teams, and external vendors.
- Create SAS programs to produce 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 submission preparations, deliverables, and regulatory responses.
- Review important planning documents (e.g., statistical analysis plan, data presentation plan, data review plan) to ensure understanding of development team goals and clarity and completeness of programming assumptions and requirements; assess impact on programming activities.
- Work with vendors regarding project standards, programming conventions, programming specifications and file transfers.
- Provide leadership for ensuring quality of deliverables by applying standards and complying with regulatory requirements, guidance and corporate and departmental SOPs and working practices.
- Identify opportunities for increased efficiency and consistency within Statistical Programming, Clinical Analytics, and interactions with vendors.
- Independently lead programming assignments.
- Lead process improvement and standards and automation projects.
Required Knowledge/ Experience:
- Demonstrated proficiency in using SAS, R, or other programming languages to produce derived analysis datasets and TFLs.
- Knowledge of CDISC standards and relational database structures.
- Experience using software tools and applications, e.g., MS office, XML, Pinnacle 21.
- Provide outputs to meet submission requirements such as ADaM datasets, define files and reviewer’s guides, etc.
- Knowledge of regulatory, industry, and technology standards.
- Knowledge of the drug development process, clinical trials, medical terminology, statistical analysis plans and protocol designs.
- Work in a team environment with clinical team members.
- Bachelor's degree (Master's Degree preferred) in Computer Science or Computer Science Engineering or equivalent field.
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.
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.
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.