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Associate Director, Statistical Programming

Avanir Pharmaceuticals, Inc
paid holidays, 401(k)
United States, Maryland, Rockville
Jul 02, 2024

Otsuka Pharmaceutical Company is a global healthcare company with the corporate philosophy: "Otsuka-people creating new products for better health worldwide." Otsuka researches, develops, manufactures and markets innovative products, with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health.

As an Associate Director, Statistical Programming, you will be a champion of Otsuka's culture and values, and will be responsible for managing various programming activities throughout all stages of the clinical development, while providing programming expertise and management to the study and project teams and programmers. You will report to the Senior Director, Statistical Programming.

This position can be based in Princeton, New Jersey, or Rockville, Maryland. Remote arrangements can also be considered. Otsuka maintains a hybrid work policy and travel is expected 20% of the time based on business needs.

Job Description:

  • Function as technical lead and project manager for studies and projects by managing all aspects of study deliverables related to Statistical Programming including validation plans.

  • Collaborate with cross-functional teams such as Biostatistics, DM and Clinical Management.

  • Manage project timelines for studies and projects and collaborates with study teams and vendors to ensure quality, on time deliverables.

  • Represent Statistical Programming in providing solutions to technical problems.

  • Adopt and follow standards, processes, validation and programming plans, and modern technology within the Statistical Programming group and D&A organization.

  • Work with the Statistical Programming leadership team to implement Statistical Programming strategy related to innovation in technologies, automation, processes, and standards to maximize efficiency.

  • Participate in Programming and company initiatives.

  • Drive and manage training compliance for resources under direct management.

  • Participate in recruiting and hiring process for qualified candidates.

  • Provide input for the selection of vendors and perform appropriate oversight of the selected vendor.

Minimum Qualifications:

  • Master's degree or equivalent with 12+ years of SAS experience in pharmaceutical industry.

  • 6+ years of experience.

  • Experience developing statistical base programming and database programming and management.

  • Excellent knowledge of SAS programming.

  • Knowledge of relational database structures.

  • Excellent knowledge of regulatory requirements.

Preferred Knowledge, Skills, and Abilities:

  • Understanding of our products, the competition, and the pharmaceutical industry.

  • Excellent written and verbal communication skills, with the ability to convey complex information to both technical and non-technical audiences.

  • Current with industry trends, latest technologies, and regulatory changes.

  • Strong organizational, problem-solving, and decision-making skills.

Our Benefits:

  • Comprehensive medical, dental, vision and prescription drug coverage

  • Company provided Basic Life, AD&D, Short-term and Long-term Disability insurance

  • Tuition reimburseme

  • 401(k) match

  • PTO allotment each calendar year, paid holidays, and paid leave programs as well as other company provided benefits



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.

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 ODH, 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.