Vanda Pharmaceuticals
Associate Director/Director, Biostatistics
Vanda Pharmaceuticals, Washington, District of Columbia, us, 20022
Join to apply for the
Associate Director/Director, Biostatistics
role at
Vanda Pharmaceuticals Join to apply for the
Associate Director/Director, Biostatistics
role at
Vanda Pharmaceuticals Working as leading statistician on multiple studies/projects across different therapeutic areas. Contribute to clinical trial design, protocol development and Clinical Study Report (CSR) Participate study related activities and provide statistical consultation, input and guidance to cross-functional groups Develop and/or review statistical documents or deliverables for clinical trials including Statistical Analysis Plan (SAP) and integrated summaries of drug efficacy and safety, TFLs, interim analysis plan and others. Manage CRO statisticians and internal biostatistics team, including junior statistician, contract statistician and programming team in support of biostatistics operational activities. Work as biostatistics function representative in clinical projects and studies. Attend project and study team meetings as needed. Support and participate activities related to regulatory requests and meetings as needed. Close communication with functional manager is expected. Provide statistical expertise by identifying potential issues, providing recommendations and bring in statistical experts external for relevant issues as needed.
Primary Responsibilities
Working as leading statistician on multiple studies/projects across different therapeutic areas. Contribute to clinical trial design, protocol development and Clinical Study Report (CSR) Participate study related activities and provide statistical consultation, input and guidance to cross-functional groups Develop and/or review statistical documents or deliverables for clinical trials including Statistical Analysis Plan (SAP) and integrated summaries of drug efficacy and safety, TFLs, interim analysis plan and others. Manage CRO statisticians and internal biostatistics team, including junior statistician, contract statistician and programming team in support of biostatistics operational activities. Work as biostatistics function representative in clinical projects and studies. Attend project and study team meetings as needed. Support and participate activities related to regulatory requests and meetings as needed. Close communication with functional manager is expected. Provide statistical expertise by identifying potential issues, providing recommendations and bring in statistical experts external for relevant issues as needed.
Requirements
Ph.D. in Biostatistics or statistics At least 4 years of pharmaceutical clinical trial experience In-depth knowledge of clinical trials methodology, regulatory requirements, statistics Comprehensive experience of SAS programming and R/S language Ability to effectively collaborate in a dynamic environment Excellent practical, organizational, interpersonal, oral and written communication skills are a must.
Additional
We are open to providing relocation for this position
The total compensation package for this position will also include incentive compensation and benefits such as health insurance, unlimited paid time off, parental leave, a 401k matching program, and other benefits to its employees.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, gender identity, sexual orientation, protected veteran status, or any other characteristic protected by law. Seniority level
Seniority level Director Employment type
Employment type Full-time Job function
Job function Science, Analyst, and Research Industries Pharmaceutical Manufacturing, Biotechnology Research, and Hospitals and Health Care Referrals increase your chances of interviewing at Vanda Pharmaceuticals by 2x Inferred from the description for this job
Medical insurance Vision insurance 401(k) Tuition assistance Paid maternity leave Child care support Disability insurance Get notified about new Associate jobs in
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Associate Director/Director, Biostatistics
role at
Vanda Pharmaceuticals Join to apply for the
Associate Director/Director, Biostatistics
role at
Vanda Pharmaceuticals Working as leading statistician on multiple studies/projects across different therapeutic areas. Contribute to clinical trial design, protocol development and Clinical Study Report (CSR) Participate study related activities and provide statistical consultation, input and guidance to cross-functional groups Develop and/or review statistical documents or deliverables for clinical trials including Statistical Analysis Plan (SAP) and integrated summaries of drug efficacy and safety, TFLs, interim analysis plan and others. Manage CRO statisticians and internal biostatistics team, including junior statistician, contract statistician and programming team in support of biostatistics operational activities. Work as biostatistics function representative in clinical projects and studies. Attend project and study team meetings as needed. Support and participate activities related to regulatory requests and meetings as needed. Close communication with functional manager is expected. Provide statistical expertise by identifying potential issues, providing recommendations and bring in statistical experts external for relevant issues as needed.
Primary Responsibilities
Working as leading statistician on multiple studies/projects across different therapeutic areas. Contribute to clinical trial design, protocol development and Clinical Study Report (CSR) Participate study related activities and provide statistical consultation, input and guidance to cross-functional groups Develop and/or review statistical documents or deliverables for clinical trials including Statistical Analysis Plan (SAP) and integrated summaries of drug efficacy and safety, TFLs, interim analysis plan and others. Manage CRO statisticians and internal biostatistics team, including junior statistician, contract statistician and programming team in support of biostatistics operational activities. Work as biostatistics function representative in clinical projects and studies. Attend project and study team meetings as needed. Support and participate activities related to regulatory requests and meetings as needed. Close communication with functional manager is expected. Provide statistical expertise by identifying potential issues, providing recommendations and bring in statistical experts external for relevant issues as needed.
Requirements
Ph.D. in Biostatistics or statistics At least 4 years of pharmaceutical clinical trial experience In-depth knowledge of clinical trials methodology, regulatory requirements, statistics Comprehensive experience of SAS programming and R/S language Ability to effectively collaborate in a dynamic environment Excellent practical, organizational, interpersonal, oral and written communication skills are a must.
Additional
We are open to providing relocation for this position
The total compensation package for this position will also include incentive compensation and benefits such as health insurance, unlimited paid time off, parental leave, a 401k matching program, and other benefits to its employees.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, gender identity, sexual orientation, protected veteran status, or any other characteristic protected by law. Seniority level
Seniority level Director Employment type
Employment type Full-time Job function
Job function Science, Analyst, and Research Industries Pharmaceutical Manufacturing, Biotechnology Research, and Hospitals and Health Care Referrals increase your chances of interviewing at Vanda Pharmaceuticals by 2x Inferred from the description for this job
Medical insurance Vision insurance 401(k) Tuition assistance Paid maternity leave Child care support Disability insurance Get notified about new Associate jobs in
Washington, DC . District of Columbia, United States $70,000.00-$100,000.00 4 weeks ago General Manager, Full Time, Arlington VA- Pottery Barn
Washington, DC $57,963.00-$107,646.00 2 weeks ago Springfield, VA $44,000.00-$56,000.00 4 days ago National Harbor, MD $15.00-$18.00 1 week ago Washington, DC $75,000.00-$87,500.00 2 weeks ago Police Officer (Entry-Level) - 50K Recruitment Incentive
Washington, DC $83,362.00-$142,513.00 2 months ago Associate, Risk and Portfolio Management
District of Columbia, United States $65,000.00-$75,000.00 2 days ago Studio & Community Associate (Part-Time) - Georgetown
Bethesda, MD $58,400.00-$72,700.00 1 week ago Washington, DC $69,909.00-$77,509.00 1 month ago Washington DC-Baltimore Area $20.00-$30.00 4 weeks ago Washington DC-Baltimore Area $55,000.00-$70,000.00 2 days ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
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