IQVIA
Principal Biostatistician FSP, Neuroscience
IQVIA, Durham, North Carolina, United States, 27703
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Principal Biostatistician FSP, Neuroscience
role at
IQVIA .
Job Level:
FSP Principal Biostatistician for Neuroscience Clinical Research 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 expert 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 novel neuroscience clinical research.
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/statistical reports and other regulatory documents
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 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 clinical trial experience in phase 2 and 3 plus 2 years in observational/RWE studies
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
Proficiency in SAS to perform analyses and validate important data derivations
Performing sample‑size/power calculations
Performing clinical trial simulations
Performing detailed literature reviews and summarization for epidemiologic data
Performing validation of Endpoints/Outcomes to inform study design
Experience with applying innovative study design and analytic techniques such as synthetic control arms, causal inference methods, rare disease methods, Bayesian techniques
Understanding of ICH GCP, ICH E9 plus general knowledge of industry practices and standards
Experience with CDISC, including SDTM, ADAM, CDASH
Desired Experience
Neuroscience experience
Employment Details
Seniority Level:
Mid‑Senior
Employment Type:
Part‑time
Job Function:
Research, Analyst, and Information Technology
Industries:
Hospitals and Health Care
Potential base pay range:
$115,900.00 – $243,900.00 annualized. 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.
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.
Learn more at https://jobs.iqvia.com
#J-18808-Ljbffr
Principal Biostatistician FSP, Neuroscience
role at
IQVIA .
Job Level:
FSP Principal Biostatistician for Neuroscience Clinical Research 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 expert 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 novel neuroscience clinical research.
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/statistical reports and other regulatory documents
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 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 clinical trial experience in phase 2 and 3 plus 2 years in observational/RWE studies
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
Proficiency in SAS to perform analyses and validate important data derivations
Performing sample‑size/power calculations
Performing clinical trial simulations
Performing detailed literature reviews and summarization for epidemiologic data
Performing validation of Endpoints/Outcomes to inform study design
Experience with applying innovative study design and analytic techniques such as synthetic control arms, causal inference methods, rare disease methods, Bayesian techniques
Understanding of ICH GCP, ICH E9 plus general knowledge of industry practices and standards
Experience with CDISC, including SDTM, ADAM, CDASH
Desired Experience
Neuroscience experience
Employment Details
Seniority Level:
Mid‑Senior
Employment Type:
Part‑time
Job Function:
Research, Analyst, and Information Technology
Industries:
Hospitals and Health Care
Potential base pay range:
$115,900.00 – $243,900.00 annualized. 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.
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.
Learn more at https://jobs.iqvia.com
#J-18808-Ljbffr