Lead Biostatistician

Lead Biostatistician
remote from anywhere in the U.S. #LI-Remote
full-time

JOB OVERVIEW
. The sponsor's focus is to develop transformational, disease-modifying therapies targeting autoimmune diseases. The company's lead candidate is a potentially best-in-class monoclonal antibody designed to inhibit the cytokine APRIL (A PRoliferation Inducing Ligand). Their pipeline also includes an anti-BAFF-R (B-cell activating factor receptor), and an anti-IFN-? monoclonal antibody.

JOB RESPONSIBILITIES
• Provide statistical support for internal biostatics program leads for 3 studies
• Ability to be a study lead for three ongoing Phase 1 studies. Oversee CRO vendor delivery of TFLs for interim analyses and final analyses.
o Collaborate with cross-functional teams, including clinical, regulatory, data management, and medical writing, to ensure statistical integrity and accuracy in all deliverables.
o Collaborate with statistical programming and clinical pharmacologists on the summarization of pharmacokinetic and pharmacodynamic data. Familiarity with ADaM datasets ADNCA and ADPDNCA a plus.
o Familiarity with PK/PD bridging studies a plus
• Assist with providing support for initial build out of TFLs for an ongoing open-label Phase 2 study for the program.
o Work closely with sponsor's statistical programmer on the validation of the internal TFLs
o Collaborate with statistical programming and data management to support ongoing study team data review
o Support abstract generation and poster/oral presentations at medical conferences. Ability to produce high-quality graphics in SAS or R or another package a plus.
• Provide support for upcoming Phase 2 and 3 studies
o Participate in CRF development
o Participate in UAT of IRT systems for randomization
o Support biostatistics lead with endpoint evaluation, sample size, and power calculations
o Review and potentially author SAPs
o Support TFL shell development
• Provide support for ongoing Phase 3 study in 2027
o Perform quality control checks on blinded outputs provided by CRO vendor in support of preparing for IDMC meetings
o Collaborate with statistical programming and data management to support ongoing study team data review

QUALIFICATIONS AND EDUCATION REQUIREMENTS
• Master's degree in Statistics, Biostatistics, or related discipline. Ph.D. preferred.
• 5-10 years experience in statistical or biostatistical analysis supporting clinical trial operations for drug development in the pharma/biotech industry
• Phase 1 experience
• 5+ years working knowledge of SAS and/or R programming languages (combined)
• Study Lead experience working with cross-functional teams. Experience leading global teams a plus.
• Experience in sample size calculation, protocol concept development, protocol development, SAP and preparing clinical study reports including integrated summaries for submissions.
• Good SAS programming skills for QCing critical outputs, Efficacy/Safety tables and working closely with Programmers. Knowledge of R programming a plus.
• Solid understanding & implementation of CDISC requirement for regulatory submissions.
• Adept in ADaM specifications generation and review of datasets.
• Effective communicator: able to explain methodology and consequences of decisions in lay terms.
• In-depth knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines Familiarity with advanced, complex statistical methods that apply to applicable clinical trials.