IQVIA
FSP Principal Biostatistician- Early Phase Clinical Development(PK)
IQVIA, Durham, North Carolina, United States, 27703
FSP Principal Biostatistician - Early Phase Clinical Development (PK)
Join to apply for the
FSP Principal Biostatistician - Early Phase Clinical Development (PK)
role at
IQVIA .
Job Level:
FSP Senior or Principal Biostatistician for Early Phase Clinical Development (PK)
Location:
Home-based in the U.S. or Canada
Seniority Level:
Mid-Senior level
Employment Type:
Part-time
Job Function:
Research, Analyst, and Information Technology
Industries:
Hospitals and Health Care
Why DSSS:
Data Sciences Staffing Solutions, DS3, 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 with sponsor teams and utilizing sponsor systems. These 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 drug development programs in early phases of development, focusing on healthy normal studies with PK and PD endpoints.
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 on project budgets and change orders
Engaging, fast-paced environment
Good work-life balance
Job Responsibilities:
Collaborate with multidisciplinary project teams to establish project timelines.
Provide statistical input to study synopses and protocols.
Write the statistical sections of clinical trial protocols, including sample size calculations, while consulting with internal and external experts.
Review eCRF and other data management documents.
Create or review randomizations and related specifications.
Write or review statistical analysis plans, dataset and TLF specifications.
Provide guidance and supervision to programmers in authoring of analysis dataset specifications and programming of tables, listings, and figures.
Provide statistical review and validation of the same.
Use SAS and/or R to perform inferential analyses and validate key data derivations.
Interpret study results and review reports of study results for accuracy.
Monitor internal and CRO project activities including timelines, deliverables, and availability of resources.
Collaborate with Data Management, Clinical Development, and Clinical Pharmacologists/PK with statistical expertise.
Contribute to clinical study reports and other regulatory documents e.g., DSURs, IB, etc.
Support exploratory analyses.
May support IND activities.
Qualifications:
PhD in Statistics, Biostatistics, or related field with 3+ years industry experience.
MS in Statistics, Biostatistics, or related field with 5+ years of industry experience.
2+ years of experience in statistical analysis of non-compartmental PK endpoints in pharmaceutical industry
Understanding of ICH GCP, regulatory guidance for clinical pharmacology studies and industry practices/standards.
Experience with CDISC, including SDTM, ADaM, CDASH.
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.
Desired Experience:
Knowledge of basic statistical modeling, simulations and PD/biomarker analyses
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com.
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. https://jobs.iqvia.com/eoe
The potential base pay range for this role, when annualized, is $115,900.00 - $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.
Referrals increase your chances of interviewing at IQVIA by 2x.
#J-18808-Ljbffr
FSP Principal Biostatistician - Early Phase Clinical Development (PK)
role at
IQVIA .
Job Level:
FSP Senior or Principal Biostatistician for Early Phase Clinical Development (PK)
Location:
Home-based in the U.S. or Canada
Seniority Level:
Mid-Senior level
Employment Type:
Part-time
Job Function:
Research, Analyst, and Information Technology
Industries:
Hospitals and Health Care
Why DSSS:
Data Sciences Staffing Solutions, DS3, 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 with sponsor teams and utilizing sponsor systems. These 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 drug development programs in early phases of development, focusing on healthy normal studies with PK and PD endpoints.
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 on project budgets and change orders
Engaging, fast-paced environment
Good work-life balance
Job Responsibilities:
Collaborate with multidisciplinary project teams to establish project timelines.
Provide statistical input to study synopses and protocols.
Write the statistical sections of clinical trial protocols, including sample size calculations, while consulting with internal and external experts.
Review eCRF and other data management documents.
Create or review randomizations and related specifications.
Write or review statistical analysis plans, dataset and TLF specifications.
Provide guidance and supervision to programmers in authoring of analysis dataset specifications and programming of tables, listings, and figures.
Provide statistical review and validation of the same.
Use SAS and/or R to perform inferential analyses and validate key data derivations.
Interpret study results and review reports of study results for accuracy.
Monitor internal and CRO project activities including timelines, deliverables, and availability of resources.
Collaborate with Data Management, Clinical Development, and Clinical Pharmacologists/PK with statistical expertise.
Contribute to clinical study reports and other regulatory documents e.g., DSURs, IB, etc.
Support exploratory analyses.
May support IND activities.
Qualifications:
PhD in Statistics, Biostatistics, or related field with 3+ years industry experience.
MS in Statistics, Biostatistics, or related field with 5+ years of industry experience.
2+ years of experience in statistical analysis of non-compartmental PK endpoints in pharmaceutical industry
Understanding of ICH GCP, regulatory guidance for clinical pharmacology studies and industry practices/standards.
Experience with CDISC, including SDTM, ADaM, CDASH.
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.
Desired Experience:
Knowledge of basic statistical modeling, simulations and PD/biomarker analyses
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com.
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. https://jobs.iqvia.com/eoe
The potential base pay range for this role, when annualized, is $115,900.00 - $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.
Referrals increase your chances of interviewing at IQVIA by 2x.
#J-18808-Ljbffr