Lead Clinical Statistician

Sajawo

Lead Clinical Statistician providing statistical leadership in clinical development at pharmaceutical company. Collaborate with clinical development and regulatory teams ensuring robust statistical strategy.

Posted 7/21/2026full-timeRemote • 🇺🇸 United StatesSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates advanced knowledge of statistical methodologies for clinical trials, including experience with SAS or R outputs, and a strong understanding of regulatory compliance and standards such as ICH and GCP. Capable of leading statistical strategy and collaborating with cross-functional teams to drive successful clinical development programs.

Highest-signal resume keywords

Statistical Methodology ExpertiseSAS/R Output ReviewClinical Trial MethodologyRegulatory Submission SupportStakeholder Management

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Hard Skills

Statistical MethodologySASRBayesian MethodsSurvival AnalysisMixed ModelsLongitudinal Data AnalysisClinical Dataset InterpretationICH E9 CDISC StandardsAdaptive Study Design

Soft Skills

CommunicationStakeholder ManagementMentoring

Tools & Technologies

Statistical ProgrammingClinical Trial Management Systems

Certifications & Qualifications

MSc in StatisticsPhD in Biostatistics

Industry Keywords

Clinical TrialsBiotechPharmaCRORegulatory ComplianceFDAEMAGCP

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Lead statistical strategy across Phase I-IV clinical studies.
Provide statistical input into clinical development plans, study design and protocol development.
Design appropriate statistical methodologies and randomisation strategies.
Author and review: SAPs, CSR, ISS, ISE.
Review outputs from statistical programmers including TFLs, ADaM datasets and analysis deliverables.
Interpret study results and communicate findings to clinical, scientific and executive stakeholders.
Collaborate closely with Clinical Operations, Data Management, Medical Writing and Regulatory Affairs.
Represent Statistics within cross-functional project teams.
Provide oversight of external CROs and statistical vendors, ensuring quality, timelines and regulatory compliance.
Contribute to regulatory submissions and support interactions with FDA, EMA and other health authorities.
Ensure statistical deliverables comply with ICH, GCP and relevant regulatory guidance.
Drive continuous improvement of statistical standards, processes and best practices.
Mentor / lead statisticians.

Requirements

What you’ll need

Advanced knowledge of statistical methodology for clinical trials.
Experience reviewing SAS or R outputs.
Familiarity with Bayesian methods or adaptive designs desirable.
Knowledge of survival analysis, mixed models and longitudinal data analysis.
Experience interpreting complex clinical datasets.
Understanding of real-world evidence and observational analyses is advantageous.
MSc or PhD in Statistics, Biostatistics, Mathematics or related quantitative discipline.
Experience within ideally fast paced biotech (or relevant Pharma / CRO).
Significant experience leading statistics for clinical development programmes.
Strong understanding of clinical trial methodology and adaptive study design.
Experience supporting regulatory submissions.
Excellent knowledge of: ICH E9 CDISC standards (ADaM/SDTM) GCP FDA and EMA statistical guidance.
Experience working with external CROs and vendors.
Strong communication and stakeholder management skills.

Benefits

Comp & perks

Great benefits package on offer.