Director, Biostatistics, Planning and Integration Lead
Apply NowCompany: Otsuka Pharmaceuticals
Location: Princeton, NJ 08540
Description:
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.
This position of Biometrics Planning and Integration Lead manages the biometrics deliverables for key drug development projects in a matrix environment. This position leverages leadership, vendor management, strategic thinking and problem-solving skills to drive consistency and operational excellence in the planning and delivery of key Biometrics data operations, dataset development, analyses and reporting through their partnership with the Biostatistical, Programming and Data Management Leads/Teams. This individual has proficiency in clinical development, biometrics, and project management and provides strategic insight into both, standard and innovative processes and related technologies that support analysis and reporting activities. This role has significant interfaces with other functions within R&D, with development partners and vendors and is accountable for tracking Biometrics timelines for critical studies, which may include data cleaning, data set generation, analyses and reporting of Phase I - Phase IV clinical trials.
Job Description
Qualifications/ Required
Knowledge/ Experience and Skills:
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.
This position of Biometrics Planning and Integration Lead manages the biometrics deliverables for key drug development projects in a matrix environment. This position leverages leadership, vendor management, strategic thinking and problem-solving skills to drive consistency and operational excellence in the planning and delivery of key Biometrics data operations, dataset development, analyses and reporting through their partnership with the Biostatistical, Programming and Data Management Leads/Teams. This individual has proficiency in clinical development, biometrics, and project management and provides strategic insight into both, standard and innovative processes and related technologies that support analysis and reporting activities. This role has significant interfaces with other functions within R&D, with development partners and vendors and is accountable for tracking Biometrics timelines for critical studies, which may include data cleaning, data set generation, analyses and reporting of Phase I - Phase IV clinical trials.
Job Description
- Translate company and departmental strategies into operational goals. Identifies necessary resources to accomplish goals and develops effective and strategic approach to delivery against the goals, in accordance with R&D priorities/timelines/strategies.
- Partners with Biometrics Leads/teams to evaluate operational readiness to meeting R&D pipeline objectives. Provides risk assessment of deliverables and follows the escalation pathway when warranted.
- Provides leadership for ensuring Biometric deliverables are delivered on time with quality for both internally or externally supported deliverables.
- Able to represent Biometrics function as an SME for effectively partnering with various cross functional stakeholders to deliver the R&D BoW. This role interacts with many stakeholders across the Development organization such as PS&AM, Regulatory, Clinical, and Operations, to align on timelines for biometrics deliverables and to provide key input into planning and risk management for upcoming milestones.
- Ensures timely planning of resources (both internal and external) to support both pipeline objectives and continuous improvement work and helps drive prioritization/tradeoff discussions
- Accountable to coordinate and conduct routine Biometric Milestone reviews and management meetings with D&A LT and necessary team members (BoW management, resources and portfolio reviews including risks and mitigations).
- Ensures regular governance with vendors including quality agreements, scorecard review, and input obtained from key Biometrics stakeholders to obtain input on vendor effectiveness
- Establishes and evaluates metrics to understand Biometrics Team effectiveness and identify emerging trends (includes across vendors and partners).
- Leads or supports Biometrics-related initiatives focused on continuous improvement, simplification of processes or cycle time improvements
- Mentors and models to Biometrics staff the contributions of the role and strong communications and project management.
Qualifications/ Required
Knowledge/ Experience and Skills:
- Graduate degree in and/or relevant experience in statistics, biostatistics, computer science or other related discipline
- At least 10 years of Pharmaceutical/R&D or other related experience in a regulated environment
- Extensive knowledge of analysis and reporting deliverables for clinical trials
- Extensive experience managing multiple, complex vendor relationships on clinical trial related activities
- Superior project management skills/experience with proven ability to manage timelines and resources across large teams/projects
- Significant experience with regulatory submissions and/or other regulated activities (Market Access, Annual Reporting, Clinical Trial Transparency)
- Demonstrated success working with Development, Regulatory, Documentation, Clinical, and Operations Leads to understand strategic objectives and priorities, and able to use this knowledge to focus teams on the right work
- Proven ability to mentor junior staff and propose/lead continuous improvement initiatives
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.