IQVIA
Principal Biostatistician FSP, Late Phase
IQVIA, Durham, North Carolina, United States, 27703
Job Level:
FSP
Principal Biostatistician, Late Phase Location:
Home-based in the U.S. or Canada Why DSSS? Data Sciences Staffing Solutions, DSSS, is a unit within IQVIA that provides our sponsors with fully embedded resources through a Functional Service Provider (FSP) partnership. This yields all the benefits of working for an industry leading global CRO and collaborating directly with cross-functional sponsor teams. Sponsor clients include world class pharmaceutical and biotech companies offering you unique opportunities to influence the future of medicine and advance therapies to market. Job Summary: The Principal Biostatistician is responsible for providing statistical support for pharmaceutical clinical trials in patients. Job Responsibilities: Collaborate with multi-disciplinary project teams to establish project objectives and timelines. Write the statistical sections of clinical trial protocols, while consulting with internal and external experts. Author statistical analysis plans. Monitor internal and CRO project activities including timelines, deliverables, and availability of resources. Collaborate with Data Management, Clinical Development, and Clinical Operations with statistical expertise. Contribute to clinical study reports and other regulatory documents, e.g. NDA, DSURs, Briefing Documents, ISS, ISE, etc. Provide guidance and supervision to programmers in authoring of analysis dataset specifications and programming/validation of tables, listings, and figures. Interpret study results and review reports of study results for accuracy. Support exploratory analyses. Participate in pre-IND or NDA activities. Participate in other activities and meetings to support Biostatistics and the Development Team as needed. Qualifications
(Minimal acceptable level of education, work experience, and competency) PhD in Statistics, Biostatistics, or related field with 5+ years industry experience. MS in Statistics, Biostatistics, or related field with 7+ years of industry experience. At least 3 years in Phase 2/3 clinical trial experience. Demonstrated ability to work pro-actively and independently. Able to effectively communicate his/her ideas and to manage programmers in a constructive manner. Ability to use R or SAS to perform efficacy and safety analyses and validate important data derivations when necessary. Understanding of ICH GCP, ICH E9 plus general knowledge of industry practices and standards. Experience with CDISC, including SDTM, ADAM, CDASH. Desired Experience: Interaction with regulators including Advisory Committee meetings. 2+ years of experience with renal therapeutic area. IQVIA is proud to be an equal opportunity employer.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. The potential base pay range for this role, when annualized, is $131,300.00 - $243,900.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.
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FSP
Principal Biostatistician, Late Phase Location:
Home-based in the U.S. or Canada Why DSSS? Data Sciences Staffing Solutions, DSSS, is a unit within IQVIA that provides our sponsors with fully embedded resources through a Functional Service Provider (FSP) partnership. This yields all the benefits of working for an industry leading global CRO and collaborating directly with cross-functional sponsor teams. Sponsor clients include world class pharmaceutical and biotech companies offering you unique opportunities to influence the future of medicine and advance therapies to market. Job Summary: The Principal Biostatistician is responsible for providing statistical support for pharmaceutical clinical trials in patients. Job Responsibilities: Collaborate with multi-disciplinary project teams to establish project objectives and timelines. Write the statistical sections of clinical trial protocols, while consulting with internal and external experts. Author statistical analysis plans. Monitor internal and CRO project activities including timelines, deliverables, and availability of resources. Collaborate with Data Management, Clinical Development, and Clinical Operations with statistical expertise. Contribute to clinical study reports and other regulatory documents, e.g. NDA, DSURs, Briefing Documents, ISS, ISE, etc. Provide guidance and supervision to programmers in authoring of analysis dataset specifications and programming/validation of tables, listings, and figures. Interpret study results and review reports of study results for accuracy. Support exploratory analyses. Participate in pre-IND or NDA activities. Participate in other activities and meetings to support Biostatistics and the Development Team as needed. Qualifications
(Minimal acceptable level of education, work experience, and competency) PhD in Statistics, Biostatistics, or related field with 5+ years industry experience. MS in Statistics, Biostatistics, or related field with 7+ years of industry experience. At least 3 years in Phase 2/3 clinical trial experience. Demonstrated ability to work pro-actively and independently. Able to effectively communicate his/her ideas and to manage programmers in a constructive manner. Ability to use R or SAS to perform efficacy and safety analyses and validate important data derivations when necessary. Understanding of ICH GCP, ICH E9 plus general knowledge of industry practices and standards. Experience with CDISC, including SDTM, ADAM, CDASH. Desired Experience: Interaction with regulators including Advisory Committee meetings. 2+ years of experience with renal therapeutic area. IQVIA is proud to be an equal opportunity employer.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. The potential base pay range for this role, when annualized, is $131,300.00 - $243,900.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.
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