Offer summary

Qualifications:

Masters or PhD degree in Biostatistics or a related field with 10+ years of relevant experience in the life-science industry., Expertise in complex statistical methods applicable to Phase 2-3 clinical trials., Strong knowledge of regulatory requirements, Good Clinical Practice (GCP), and ICH guidelines., Proficient in SAS or R, with excellent communication and collaboration skills..

Key responsibilities:

Serve as a biostatistical consultant and lead statistician on major projects, ensuring scientific integrity and regulatory compliance.

Participate in the development and review of clinical development plans, protocols, and statistical analysis plans.

Lead the database lock and unblinding process, and provide expert statistical input into deliverables.

Identify and mitigate risks to project delivery and quality, while maintaining knowledge of biostatistics and clinical trial methodology developments.

Job description

Job Overview:

As an Associate Biostatistics Director, you will liaise with cross-functional teams, to drive the quality statistical planning, analysis and reporting in support of pharmaceutical development and regulatory submissions. Serve as a resource for the department, ensuring scientific integrity and regulatory compliance in the application of statistical methodology to clinical trials. 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 in independent research activities, teaching opportunities, presentations, and preparation of manuscripts for publication

Participate as high level lead biostatistician on major projects, including developing/reviewing protocols, preparing analysis plans, and writing sections of joint clinical/statistical reports, integrated summaries and/or NDA sections

Leading studies at an operational level

Provide expert review and initiate methodology development work with regards to statistical standards and validation procedures

Consult on operational/statistical/therapeutic area topics

Knowledge Sharing:

Maintain knowledge and awareness of developments in biostatistics and clinical trial methodology, and regulatory requirements that impact on analyses

Performs as subject matter expert (SME)

Risk Management:

Identifies risks to project delivery and/or quality, leads in a way to minimize risks

Anticipates risks to avert need for study level escalations, supports lead in implementing risk mitigation actions

Lock and Unblinding Process:

Leads the database lock and unblinding process for the statistical team

Participate on the biostatistics randomization team (drafts randomization specifications and/or perform quality control (QC) review of randomization schedules)

Statistical Expertise:

Provide expert statistical input into 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

Requirements:

Masters or PhD degree in Biostatistics or a related field and 10+ years’ relevant experience within the life-science industry
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
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 pro-active problem solving skills
Rare disease and immunology experience is greatly preferred.

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

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