Principal Biostatistician FSP, R Regulatory Submission
Principal Biostatistician FSP, R Regulatory Submission Principal Biostatistician FSP, R Regulatory Submission Apply locations: Durham, North Carolina, United States of America Time type: Full time Posted on: Posted 4 Days Ago Job requisition id: R1451351 Job Level: FSP Principal Biostatistician - R Regulatory Submission and Multiple Imputations 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 means you get all the benefits of working for an industry-leading global CRO while collaborating directly with cross-functional sponsor teams. Job Summary: The Principal Biostatistician is responsible for providing statistical support for clinical trials in patients. Additional Benefits:
- Home-based remote working opportunities
- Work/life balance as well as flexible schedules
- Collaborating with motivated, high-performance, statistical and research teams
- Technical training and tailored development curriculum
- Research opportunities that match your unique skillset
- Promising career trajectory
- Job stability: long-term engagements and re-deployment opportunities
- Focus on bringing new therapies to market rather than project budgets and change orders
- Experience with regulatory submissions
- Engaging, fast-paced environment
- Good work-life balance
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
- Write 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., DSURs, Briefing Documents, etc.
- Provide guidance and supervision to programmers in authoring of analysis dataset specifications and programming of tables, listings, and figures
- Interpret study results and review reports of study results for accuracy
- Support exploratory analyses and medical affairs publications
- Participate in pre-IND and NDA activities
- Participate in other activities and meetings to support Biostatistics and the Development Team as needed
Qualifications:
- 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 independently in project management and decision making
- Able to effectively communicate his/her ideas and to manage programmers in a constructive manner
- Ability to use R 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
- 2+ years supporting multiple imputation analyses
- Experience with CDISC, including SDTM, ADAM, CDASH
Desired Experience:
- Interaction with regulators including Advisory Committee meetings
- 2+ years of experience with Immunology therapeutic area and regulatory submissions
#LI-Remote #LI-NITINMAHAJAN IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. 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. #J-18808-Ljbffr Salary: USD 72000 - 108000 per year Experience: 5 years required Apply tot his job Apply To this Job