Associate/Director of Biostatistics, Early Phase Pharmacodynamics

Job Level: Associate/Director of Biostatistics, Early Phase Pharmacodynamics

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

Job Overview:

As an (Associate) Director, you will liaise with cross-functional teams to drive quality statistical planning, analysis, and reporting in support of early phase pharmaceutical development with focus on pharmacodynamics. Serve as a resource for the department, ensuring scientific integrity and regulatory compliance in the application of statistical methodology to clinical trials, particularly in the area of pharmacodynamics, as they apply to phase I studies of central nervous system (CNS)-acting compounds, including abuse potential and dependence, drug-drug interactions, proof of concept.  Proactively support business development efforts in these and related areas.  Participate as lead statistician on new or potential project opportunities, 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.
•  Participate as high-level lead biostatistician on major projects, including developing/reviewing synopses, protocols, analysis plans, and writing sections of clinical development plans, statistical reports, integrated summaries, and/or NDA sections.
• Develops new and increased contract awards for complex phase I studies of CNS-acting compounds by developing client contacts, providing strong scientific/statistical support, participating in proposal reviews and bid defenses, and supporting overall client satisfaction.
• Supports marketing and scientific outreach and engages with key stakeholders such as members of the Cross-Company Abuse Liability Council (C-CALC).
• Supports scientific innovation and business growth by developing new statistical methods for new studies and regulatory guidelines.
• Assists in recruitment, retention, and mentoring of Biostatisticians to support complex phase I studies of CNS-acting compounds.
•  Maintain knowledge and awareness of developments in biostatistics and clinical trial methodology, and regulatory requirements that impact analyses.

Knowledge Sharing:

• Maintains compliance and ensures awareness of regulatory guidelines of related authorities (Therapeutic Products Directorate [TPD], Food and Drug Administration [FDA], European Medicines Agency [EMA], etc) as well as the International Conference on Harmonization (ICH) and Good Clinical Practice (GCP) procedures.
• Collaboratively develops and conducts pharmacodynamic training for Statistical Programming and Biostatistics teams.
• Develops and shares scientific and biostatistical expertise to meet client needs for complex phase I studies of CNS-acting compounds.

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).
• Perform senior biostatistical review (SBR).
•  Produce or perform quality control review of sample size calculations for complex studies.
• Supports scientific innovation and business growth by developing new statistical methods for new studies and regulatory guidelines.

Requirements:

• MS or PhD degree in Biostatistics or a related field and 7+ years’ relevant experience within the life-science industry.
•  Expert in a broad range of complex statistical methods that apply to Phase 1 and 2a clinical trials.
• Expert in strategically collaborating with clinical and drug development experts within sponsors and the company.
• Maintains compliance and ensures awareness of regulatory guidelines of related authorities (Therapeutic Products Directorate [TPD], Food and Drug Administration [FDA], European Medicines Agency [EMA], etc.) as well as the International Conference on Harmonization (ICH) and Good Clinical Practice (GCP) procedures.
• Understanding of clinical research, statistical principles, drug development process, and applicable regulatory guidelines as they relate to complex phase I studies of CNS-acting compounds.
• Strong working knowledge of SAS or R.
• Excellent knowledge of CDISC Data Standards.
• Superb communication and collaboration skills.
• Independent and proactive problem-solving skills
• Ability to acquire and apply knowledge quickly.
• Flexible attitude and an ability to effectively prioritize.

#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. 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