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Job Level: Senior/Director of Biostatistics,Rare Disease, FSP

Location:Home-based in the U.S. or Canada(East Coast Preferred)

Job Overview:

As a Director, you will lead cross-functional teams to drive quality statistical strategy, planning, analysis, and reporting in support of pharmaceutical development and regulatory submissions. You will serve as a valued resource for the department, ensuring scientific integrity and regulatory compliance in the application of statistical methodology to clinical trial research. Participate as lead statistician on major projects, including contributing to clinical development plans, developing/reviewing protocols, preparing/reviewing analysis plans, overseeing the conduct of analyses, preparing/reviewing integrated clinical and statistical reports, and responding to regulatory queries.

Key Responsibilities:

Leadership:

- Serve as a biostatistical consultant for other members of the department and staff members from other Biostatistics departments within the company.
- Represent sponsors at meetings with regulatory agencies or other regulatory meetings, may participate as a member of a Data and Safety Monitoring Committee.
- Participate as high-level lead biostatistician on major projects, including developing/reviewing protocols, analysis plans, and writing sections of clinical/statistical reports, integrated summaries, and/or NDA sections.
- Lead development programs a strategic level, to understand the asset well and maximize the its chances of success.
- Provide expert review and initiate methodology work with regards to statistical standards and regulatory .
- Consult on strategic/operational/statistical/therapeutic area topics.

- May represent sponsor and biostatistics to Health Authorities and Reimbursement/Payer Organizations or internal governance committees

Knowledge Sharing:

- Maintain knowledge and awareness of developments in biostatistics and clinical trial methodology, and regulatory requirements that impact analyses.
- Perform as subject matter expert (SME).

Risk Management:

- Proactively identify risks to project delivery, success and quality, lead in a way to minimize these risks, to avert escalations, support leads in implementing risk mitigation actions.

Statistical Expertise:

- Provide expert statistical input into the review of statistical deliverables (i.e., statistical section of a protocol, statistical analysis plans, table shells, programming and table specifications, data review, tables, listings, figures, and statistical sections for complex and/or integrated reports).
- Provide expert input into data management deliverables (i.e., database design, CRF design, validation checks, and critical data).
- Provide expert review of ADaM reviewers guide (ADRG) and metadata.
- Perform senior biostatistical review (SBR).
- Produce or perform quality control review of sample size calculations for complex studies.

-Statistical problem-solving skills to overcome data or analytical challenges

Requirements:

- MS or PhD degree in Biostatistics or a related field and 10+ years’ relevant experience within the life-science industry.  PhD preferred.
- Expert in a broad range of complex statistical methods that apply to Phase 2-3 clinical trials.
- Expert in strategically collaborating with clinical and drug development experts.
- Experience in serving as statistical lead for regulatory submissions, including preparation of submission datasets, eCTD support, meeting with regulatory teams, and responding to regulatory queries.

- Strong understanding of multiple imputation methodologies.
- In-depth knowledge of applicable clinical research regulatory requirements, Good Clinical Practice (GCP), and International Conference on Harmonization (ICH) guidelines.
- Strong working knowledge of SAS or R.
- Excellent knowledge of CDISC Data Standards.
- Superb communication and collaboration skills.
- Independent and proactive problem-solving skills.
- Rare disease and immunology experience is greatly preferred.

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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 $161,100.00 - $299,100.00. 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.