Director of Biostatistics Job at Otsuka Pharmaceutical Co.
The Director of Biostatistics will oversee statistical work in early and late development phases for multiple compounds. You will be a necessary member of core project teams. In collaboration with cross functional team members, you will be responsible for Biostatistics for development of the compound(s), including efficient and effective trial design, analysis planning, modeling and simulation, submission reporting, advisory committee preparation and participation. You will ensure scientific rigor when applying statistical methods in clinical trials and will manage biostatisticians and mentor their career development.
Job Description
Collaborate with other functions, such as clinical, clinical pharmacology, clinical operations and regulatory.
Responsible for ensuring scientific rigor when applying statistical methods in clinical trials.
Provide statistical expertise/input in the clinical development plan.
Provide technical guidance to statisticians to ensure quality deliverables.
Provide statistical support for development of protocols, SAP, CSR, summary documents, and briefing book for various regulatory interactions.
Support regulatory interactions and participate in regulatory meetings and addresses statistical questions Participate in company-wide or functional projects, such as related to process improvements.
Work with senior leaders and maintains close communication with partners both within and outside of the function.
Engage with external statistical community and have awareness of new statistical methodology and regulatory guidance.
Qualifications
PhD or M.S. in Statistics or Biostatistics.
Minimum of 10 (or 12 for M.S.) years of experience in the pharmaceutical or related industry.
Experience in early phase development preferred.
Management experience preferred
.
Knowledge/Experience and Skills
Strong knowledge of clinical trial development and regulatory guidance.
Strong working knowledge of regulatory submissions for NDA and sNDA • Demonstrate ability to work in a team environment.
Demonstrate ability to oversee junior statisticians.
In-depth knowledge of statistical principles and applications.
Strong computer skills such as SAS, R and other statistical software.
#MS1
Annual Salary :
Minimum $0.00 - Maximum $0.00, plus annual incentive: The range shown represents a typical pay range or starting salary for candidates hired to perform the work. Other elements may be used to determine actual salary such as the candidate’s job experience, specific skills, and comparison to internal incumbents currently in role. This information is provided to applicants in accordance with states and local laws.
Come discover more about Otsuka and our benefit offerings; https://www.otsuka-us.com/careers-join-otsuka.
Company benefits: Comprehensive medical, dental, vision and prescription drug coverage, company provided Basic Life, AD&D, Short-term and Long-term Disability insurance, tuition reimbursement, a 401(k) match, PTO allotment each calendar year, paid holidays, and paid leave programs as well as other company provided benefits.
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 receive consideration for employment without regard to their protected veteran or disabled status, or any protected status.
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.
Please Note :
caminobluff.com is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, caminobluff.com provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, Site.com is the ideal place to find your next job.
Job Description
Collaborate with other functions, such as clinical, clinical pharmacology, clinical operations and regulatory.
Responsible for ensuring scientific rigor when applying statistical methods in clinical trials.
Provide statistical expertise/input in the clinical development plan.
Provide technical guidance to statisticians to ensure quality deliverables.
Provide statistical support for development of protocols, SAP, CSR, summary documents, and briefing book for various regulatory interactions.
Support regulatory interactions and participate in regulatory meetings and addresses statistical questions Participate in company-wide or functional projects, such as related to process improvements.
Work with senior leaders and maintains close communication with partners both within and outside of the function.
Engage with external statistical community and have awareness of new statistical methodology and regulatory guidance.
Qualifications
PhD or M.S. in Statistics or Biostatistics.
Minimum of 10 (or 12 for M.S.) years of experience in the pharmaceutical or related industry.
Experience in early phase development preferred.
Management experience preferred
.
Knowledge/Experience and Skills
Strong knowledge of clinical trial development and regulatory guidance.
Strong working knowledge of regulatory submissions for NDA and sNDA • Demonstrate ability to work in a team environment.
Demonstrate ability to oversee junior statisticians.
In-depth knowledge of statistical principles and applications.
Strong computer skills such as SAS, R and other statistical software.
#MS1
Annual Salary :
Minimum $0.00 - Maximum $0.00, plus annual incentive: The range shown represents a typical pay range or starting salary for candidates hired to perform the work. Other elements may be used to determine actual salary such as the candidate’s job experience, specific skills, and comparison to internal incumbents currently in role. This information is provided to applicants in accordance with states and local laws.
Come discover more about Otsuka and our benefit offerings; https://www.otsuka-us.com/careers-join-otsuka.
Company benefits: Comprehensive medical, dental, vision and prescription drug coverage, company provided Basic Life, AD&D, Short-term and Long-term Disability insurance, tuition reimbursement, a 401(k) match, PTO allotment each calendar year, paid holidays, and paid leave programs as well as other company provided benefits.
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 receive consideration for employment without regard to their protected veteran or disabled status, or any protected status.
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.
Please Note :
caminobluff.com is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, caminobluff.com provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, Site.com is the ideal place to find your next job.