Lead Study Statistician (100% Remote)

Lead Study Statistician 12 Months (Possibility of Extension) Thousand Oaks, CA 91320 (100% remote)

Shift Hours/Schedule: Some flexibility needed by generally a standard 8-hour workday aligned with client core business hours depending on their time zone.
Overtime: May have some OT but not guaranteed.

Top 3 Must Have Skill Sets:

• R shiny app experience
• Clinical trial statistician experience (2 3+ years).
• Gitlab
• Master s degree in Statistics or related field.

Nice-to-Haves:

• Broader pharmaceutical/biotech exposure.
• Relevant therapeutic area knowledge (not required).
• Demonstrated ability to lead or support clinical trial teams.

Day to Day Responsibilities:

• R shiny app development
• Clinical trial statistician, programming, cross-functional collaboration

Basic Qualifications:

• Masters degree in statistics/biostatistics or other subject with high statistical content with at least 4 years of post-graduate statistical experience in the pharmaceutical industry or medical research (or PhD degree with at least 3 years experience)

Minimum Qualifications:

• Master s degree in Statistics/Biostatistics or related field with high statistical content and at least 4 years of post-graduate experience in pharma or medical research, or PhD with at least 3 years of experience.
• Strong written and verbal communication skills.
• Deep understanding of statistical concepts in clinical study design and analysis.
• Proven ability to lead statistical aspects of complex studies.
• Experience developing and executing protocols and SAPs, and reviewing CSRs.
• Proficiency in R programming, including simulations and statistical applications for complex study designs.
• Experience with R Shiny app development and management.

Preferred Qualifications:

• Master s degree with 6+ years or PhD with 5+ years of relevant experience.
• End-to-end leadership of at least three clinical studies or projects.
• Experience presenting and defending statistical findings in internal and external settings.
• Life cycle drug development experience across pre-clinical, clinical, and post-marketing phases.
• Proven ability to work cross-functionally and influence decision-making.
• Experience with adaptive trial designs and Bayesian statistical methods.
• Advanced R programming skills, including Shiny app development for clinical trial data.

Description: Ideal Candidate Traits: Team-oriented, punctual, communicative, quality-driven, and detail-focused.
Resume Highlights: Experience with R Shiny app development, clinical trial work, 3 5+ years in the pharmaceutical industry, and a postgraduate degree in statistics or a related field. andidates with SAS-only backgrounds or vague, nonspecific resumes will not be considered.
Role Overview

• The Study Lead Statistician (SLS) for product-facing work leads statistical activities for clinical studies. This role collaborates closely with cross-functional teams to ensure studies are well-designed, statistically sound, compliant with regulatory standards, and aligned with client s internal practices. The SLS ensures operational and statistical integrity throughout the study lifecycle and supports product-level activities such as regulatory submissions and publications.
• The SLS partners with the Global Statistical Lead to align study-level work with overall product strategy and works alongside the Study Statistician, who manages operational statistical deliverables.

Core Responsibilities:

• Provide statistical input and review for protocols, SAPs, TFL shells, DMC charters, SDF specifications (SDTM and ADaM), randomization specs, and other study documentation.
• Participate in Clinical Study Team meetings and cross-functional study start-up activities (e.g., CRF development, database specs, IVRS review).
• Lead and coordinate team meetings for SAP and TFL reviews.
• Conduct and document statistical analyses for individual studies.
• Perform QC of ADaM datasets and key endpoints.
• Apply data-driven modeling during clinical studies.
• Prepare outputs for Dose Level Review Meetings and participate in DLRMs.
• Review TFLs for accuracy and consistency.
• Author analysis reports including Flash Memos and CSR results sections.
• Collaborate with programming teams on deliverables.
• Manage timelines for statistical outputs across cross-functional teams.
• Maintain familiarity with company policies, SOPs, and controlled documents.
• Support internal and external audits.

Red Flags:

• Lack of clinical trial statistical experience.
• Candidates with only SAS programming and no R Shiny. (must have R shiny experience)
• Poorly written/unclear resumes vague descriptions or generic fluffy language without specifics on trial phases, deliverables, or contributions.
• Resumes where the hiring manager cannot form targeted questions from the details provided.

Interview Process: 1 virtual Interview

At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position's starting pay is: $75.00/hr.