Executive Director Biostatistics

The Lotus Group LLC; California; Sur place; USD 180 000 - 290 000; Plein temps

Résumé du poste

The Lotus Group LLC in California seeks a senior leader to run statistics for global Medical Affairs across multiple therapeutic areas. The role owns statistical strategy for evidence generated post-approval, including Phase 3b/4 trials, real world evidence, investigator-initiated research, publications, and payer evidence.

Reporting to the Head of Global Biostatistics, this leader sits on the Medical Affairs and Biostatistics leadership teams.

Qualifications

• PhD in Biostatistics, Statistics, or a related quantitative field.
• 15+ years in pharma or biotech.
• Experience leading statistics for post-approval evidence.
• Global regulatory submissions experience.
• Proven ability to influence decisions with senior leaders.

Responsabilités

• Set statistical strategy for Medical Affairs evidence generation across the portfolio.
• Define evidence gaps with cross-functional leaders and design studies.
• Provide input on Phase 3b/4, pragmatic trials, registries and observational studies.
• Own deliverables for sponsored studies: protocols, SAPs, interim analyses, CSRs.
• Lead statistical reviews of investigator-sponsored studies.
• Ensure compliance with ICH E9, E9(R1), GCP, and SOPs.
• Direct RWE studies with causal inference and target trial emulation.
• Oversee publications, abstracts, HTA and payer submissions.
• Lead the function team, budget, CRO/FSP partnerships.
• Foster capability in RWE, Bayesian design, and HTA evidence.

Connaissances

Biostatistics

Leadership

Regulatory submissions

Bayesian design

RWE methods

Causal inference

Study design

Team management

External collaboration

Publications

Formation

PhD in Biostatistics or related field

Outils

R

SAS

Description du poste

This leader runs the statistics function for global Medical Affairs across multiple therapeutic areas.

The role owns statistical strategy for evidence generated after approval and across the product lifecycle: Phase 3b and 4 trials, real world evidence, investigator sponsored research, publications, and payer evidence.

The role reports to the Head of Global Biostatistics and sits on the Medical Affairs and Biostatistics leadership teams.

What you will do

Statistical strategy and evidence planning

• Set statistical strategy for Medical Affairs evidence generation across the portfolio, tied to integrated evidence plans and lifecycle management.
• Work with Medical Affairs, Clinical Development, and Market Access leaders to define evidence gaps and the study designs that close them.
• Advise on designs for Phase 3b and 4 trials, pragmatic trials, registries, and observational studies, including estimands, Bayesian approaches, and external controls.
• Provide statistical input to launch readiness, label expansion, and health authority interactions where Medical Affairs data are in scope.

Study execution and quality

• Own statistical deliverables for Medical Affairs sponsored studies: protocols, statistical analysis plans, interim analyses, and clinical study reports.
• Set standards for post hoc, exploratory, and pooled analyses so outputs are reproducible and defensible to regulators, payers, and journals.
• Lead statistical review of investigator sponsored study proposals and collaborative research.
• Maintain compliance with ICH E9 and E9(R1), GCP, and internal SOPs.

Real world evidence

• Direct statistical methods for studies using claims, EHR, registry, and linked data, including causal inference, propensity score methods, and target trial emulation.
• Work with Epidemiology, HEOR, and RWE teams on study design, data source selection, and interpretation.

Scientific communication and payer evidence

• Oversee the statistical content of publications, congress abstracts, medical communication materials, and medical information responses.
• Support HTA and payer submissions, including indirect treatment comparisons and network meta analyses.
• Govern responses to external data sharing requests and secondary use of trial data.
• Represent the company's statistical position with external experts, advisory boards, and at congresses.

Leading the function

• Lead team of direct reports
• Own the function budget and CRO and FSP partnerships, including the in house versus FSP mix.
• Set priorities and resourcing across marketed products and launch programs when demand exceeds capacity.
• Build, develop, and retain the team, including succession plans for each Director.
• Build capability in RWE methods, Bayesian design, and HTA evidence as the portfolio requires.
• Hold the line on scientific integrity when business requests would compromise it, and explain the reasoning to medical, commercial, and executive audiences.

What you bring

• PhD in Biostatistics, Statistics, or a related quantitative field with 15 or more years in pharma or biotech
• 8 or more years leading people, including managing managers and teams across regions.
• Direct experience leading statistics for post approval evidence: Phase 3b and 4 trials, observational research, and publications.
• Experience with global regulatory submissions and health authority interactions.
• Working command of RWE methods: causal inference, propensity scores, missing data, and sensitivity analyses.
• Experience managing CRO and FSP partners and a function budget.
• A record of explaining statistical conclusions to senior medical and commercial leaders and influencing decisions without formal authority.