Senior Principal Biostatistician
GLOBAL Recruitment Solutions LLC, Paramus, NJ, United States
Location:
Paramus, NJ Work Arrangement:
Onsite Job Type:
Contract
A growing pharmaceutical organization is seeking an experienced
Biostatistics leader
to support clinical development programs from
protocol design through final study reporting, regulatory submissions, and post-study analysis . This role will lead key statistical activities across clinical trials and work closely with cross-functional teams, programmers, data management, and external partners to ensure high-quality statistical deliverables and timely execution.
Key Responsibilities
Lead statistical support for clinical trials from protocol development through final study report
Review study protocols and prepare statistical sections, including study design inputs, sample size calculations, analysis methods, and study duration assumptions
Review CRFs, database design, and edit check specifications to support quality data collection
Prepare and/or review Statistical Analysis Plans, TFL shells, and variable derivation specifications
Partner with Statistical Programming and Clinical Data Management to identify and resolve data quality issues impacting key efficacy and safety endpoints
Provide statistical review and validation support for analysis datasets, outputs, and tables/listings/figures
Review study reports, manuscripts, and other scientific or regulatory documents with statistical content
Support regulatory submissions by contributing statistical input and performing additional analyses requested by health authorities
Monitor timelines and deliverables related to biostatistics and statistical programming
Oversee CRO statistical activities and review vendor deliverables for quality and compliance
Collaborate effectively with clinical, regulatory, data management, medical writing, and external vendor teams
Perform additional statistical projects and ad hoc analyses as needed
Required Qualifications
PhD in Statistics or Biostatistics with at least 4 years of pharmaceutical or CRO industry experience, or MS in Statistics/Biostatistics with at least 6 years of relevant industry experience
Strong SAS programming knowledge
Deep understanding of
ICH guidelines, CDISC standards, and FDA regulatory expectations
Hands‑on experience with: Protocol statistical review
Sample size calculation
SAP development
TFL shells and output specifications
CRF review
Database design review
Edit check specifications
Analysis dataset review and validation
Regulatory response support
CRO oversight
Strong communication, organizational, and time management skills
Ability to work independently while also leading cross‑functional collaboration
Proven ability to manage multiple priorities and meet aggressive deadlines
Preferred Background
Experience supporting regulatory filings and health authority responses
Experience contributing to drug development programs, study reports, and publication‑related statistical content
Ability to provide leadership and direction to CRO statisticians and statistical programmers
Core Competencies
Strong analytical and problem‑solving skills
High attention to detail
Ability to adapt quickly in a fast‑paced clinical development environment
Composed and effective under pressure
Strong written and verbal communication skills
Ideal Candidate Profile This opportunity is best suited for a statistician or biostatistician with strong
clinical trial experience in pharma or CRO settings , solid command of
regulatory and industry standards , and the ability to lead statistical strategy while partnering effectively across multiple functions.
#J-18808-Ljbffr
Paramus, NJ Work Arrangement:
Onsite Job Type:
Contract
A growing pharmaceutical organization is seeking an experienced
Biostatistics leader
to support clinical development programs from
protocol design through final study reporting, regulatory submissions, and post-study analysis . This role will lead key statistical activities across clinical trials and work closely with cross-functional teams, programmers, data management, and external partners to ensure high-quality statistical deliverables and timely execution.
Key Responsibilities
Lead statistical support for clinical trials from protocol development through final study report
Review study protocols and prepare statistical sections, including study design inputs, sample size calculations, analysis methods, and study duration assumptions
Review CRFs, database design, and edit check specifications to support quality data collection
Prepare and/or review Statistical Analysis Plans, TFL shells, and variable derivation specifications
Partner with Statistical Programming and Clinical Data Management to identify and resolve data quality issues impacting key efficacy and safety endpoints
Provide statistical review and validation support for analysis datasets, outputs, and tables/listings/figures
Review study reports, manuscripts, and other scientific or regulatory documents with statistical content
Support regulatory submissions by contributing statistical input and performing additional analyses requested by health authorities
Monitor timelines and deliverables related to biostatistics and statistical programming
Oversee CRO statistical activities and review vendor deliverables for quality and compliance
Collaborate effectively with clinical, regulatory, data management, medical writing, and external vendor teams
Perform additional statistical projects and ad hoc analyses as needed
Required Qualifications
PhD in Statistics or Biostatistics with at least 4 years of pharmaceutical or CRO industry experience, or MS in Statistics/Biostatistics with at least 6 years of relevant industry experience
Strong SAS programming knowledge
Deep understanding of
ICH guidelines, CDISC standards, and FDA regulatory expectations
Hands‑on experience with: Protocol statistical review
Sample size calculation
SAP development
TFL shells and output specifications
CRF review
Database design review
Edit check specifications
Analysis dataset review and validation
Regulatory response support
CRO oversight
Strong communication, organizational, and time management skills
Ability to work independently while also leading cross‑functional collaboration
Proven ability to manage multiple priorities and meet aggressive deadlines
Preferred Background
Experience supporting regulatory filings and health authority responses
Experience contributing to drug development programs, study reports, and publication‑related statistical content
Ability to provide leadership and direction to CRO statisticians and statistical programmers
Core Competencies
Strong analytical and problem‑solving skills
High attention to detail
Ability to adapt quickly in a fast‑paced clinical development environment
Composed and effective under pressure
Strong written and verbal communication skills
Ideal Candidate Profile This opportunity is best suited for a statistician or biostatistician with strong
clinical trial experience in pharma or CRO settings , solid command of
regulatory and industry standards , and the ability to lead statistical strategy while partnering effectively across multiple functions.
#J-18808-Ljbffr