Principal/Senior Manager Biostatistician – Clinical Trials
Confidential Recruiting Partners
Behavioral Health Market Context
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Job Description
| No Relocation Assistance
Contract Duration: 5 months | W2
Work Schedule: Monday-Friday, 9AM-5PM
Local candidates only (within ~1 hour commute) or those willing to secure short‑term local housing at their own expense
Requirements:
• Monitor study conduct and review study‑quality surveillance outputs.
• Provide statistical oversight for analysis datasets, TFLs, and validation activities.
• Review clinical study reports, manuscripts, and other statistical documentation.
• Review clinical protocols and develop statistical sections, including study design elements, sample‑size calculations, and analysis methodologies.
• Review CRFs, database structures, edit‑check specifications, and data‑collection elements to ensure statistical adequacy.
• Develop and/or review Statistical Analysis Plans (SAPs), TFL shells, and derivation specifications.
• Collaborate with Statistical Programmers and Data Management to identify and resolve data‑quality issues for key efficacy and safety endpoints.
• Support regulatory submissions, including preparing responses to health‑authority questions and executing additional analyses as required.
• Provide leadership and oversight to CRO statisticians and statistical programmers, ensuring high‑quality deliverables and adherence to timelines.
• Partner effectively with cross‑functional teams including Clinical, Regulatory, Programming, and Data Management.
• Perform additional statistical tasks as needed to support clinical development objectives.
• Lead statistical activities across assigned clinical studies from design through reporting.
Qualifications (Must-Haves)
• Advanced proficiency in SAS for clinical‑trial analysis.
• Must be able to work fully onsite in Paramus, NJ.
• Excellent communication, organizational, and time‑management skills.
• Strong knowledge of ICH guidelines, FDA regulatory expectations, and CDISC standards (SDTM/ADaM)
• Demonstrated experience authoring SAPs, performing sample‑size calculations, and reviewing TFLs and analysis datasets.
• Hands‑on experience reviewing CRFs, database designs, and edit‑check specifications.
• Proven ability to oversee CRO statisticians/programmers and manage statistical deliverables.
• Ability to work independently and collaboratively within cross‑functional teams.
• PhD in Statistics/Biostatistics with 4+ years of pharmaceutical/CRO experience OR MS in Statistics/Biostatistics with 6+ years of experience.
Preferred Skills:
• Experience with late‑phase or pivotal clinical trials.
• Prior leadership of multiple concurrent studies.
• Experience supporting regulatory submissions (e.g., IND, NDA, BLA, MAA)
• Familiarity with R or other statistical tools (optional but beneficial)
Contract Duration: 5 months | W2
Work Schedule: Monday-Friday, 9AM-5PM
Local candidates only (within ~1 hour commute) or those willing to secure short‑term local housing at their own expense
Requirements:
• Monitor study conduct and review study‑quality surveillance outputs.
• Provide statistical oversight for analysis datasets, TFLs, and validation activities.
• Review clinical study reports, manuscripts, and other statistical documentation.
• Review clinical protocols and develop statistical sections, including study design elements, sample‑size calculations, and analysis methodologies.
• Review CRFs, database structures, edit‑check specifications, and data‑collection elements to ensure statistical adequacy.
• Develop and/or review Statistical Analysis Plans (SAPs), TFL shells, and derivation specifications.
• Collaborate with Statistical Programmers and Data Management to identify and resolve data‑quality issues for key efficacy and safety endpoints.
• Support regulatory submissions, including preparing responses to health‑authority questions and executing additional analyses as required.
• Provide leadership and oversight to CRO statisticians and statistical programmers, ensuring high‑quality deliverables and adherence to timelines.
• Partner effectively with cross‑functional teams including Clinical, Regulatory, Programming, and Data Management.
• Perform additional statistical tasks as needed to support clinical development objectives.
• Lead statistical activities across assigned clinical studies from design through reporting.
Qualifications (Must-Haves)
• Advanced proficiency in SAS for clinical‑trial analysis.
• Must be able to work fully onsite in Paramus, NJ.
• Excellent communication, organizational, and time‑management skills.
• Strong knowledge of ICH guidelines, FDA regulatory expectations, and CDISC standards (SDTM/ADaM)
• Demonstrated experience authoring SAPs, performing sample‑size calculations, and reviewing TFLs and analysis datasets.
• Hands‑on experience reviewing CRFs, database designs, and edit‑check specifications.
• Proven ability to oversee CRO statisticians/programmers and manage statistical deliverables.
• Ability to work independently and collaboratively within cross‑functional teams.
• PhD in Statistics/Biostatistics with 4+ years of pharmaceutical/CRO experience OR MS in Statistics/Biostatistics with 6+ years of experience.
Preferred Skills:
• Experience with late‑phase or pivotal clinical trials.
• Prior leadership of multiple concurrent studies.
• Experience supporting regulatory submissions (e.g., IND, NDA, BLA, MAA)
• Familiarity with R or other statistical tools (optional but beneficial)
Qualifications
- •Advanced proficiency in SAS for clinical‑trial analysis
- •Must be able to work fully onsite in Paramus, NJ
- •Excellent communication, organizational, and time‑management skills
- •Strong knowledge of ICH guidelines, FDA regulatory expectations, and CDISC standards (SDTM/ADaM)
- •Demonstrated experience authoring SAPs, performing sample‑size calculations, and reviewing TFLs and analysis datasets
- •Hands‑on experience reviewing CRFs, database designs, and edit‑check specifications
- •Proven ability to oversee CRO statisticians/programmers and manage statistical deliverables
- •Ability to work independently and collaboratively within cross‑functional teams
- •PhD in Statistics/Biostatistics with 4+ years of pharmaceutical/CRO experience OR MS in Statistics/Biostatistics with 6+ years of experience
Benefits
- •Contract Duration: 5 months | W2
- •Work Schedule: Monday-Friday, 9AM-5PM
- •Local candidates only (within ~1 hour commute) or those willing to secure short‑term local housing at their own expense
Responsibilities
- •Our client is seeking a Senior Manager/Principal‑Level Statistician to provide statistical leadership across clinical trials from protocol development through final study reporting
- •This role supports clinical development, regulatory submissions, and cross‑functional study teams, and requires strong hands‑on expertise with SAS, CDISC standards, and FDA/ICH guidelines
- •Monitor study conduct and review study‑quality surveillance outputs
- •Provide statistical oversight for analysis datasets, TFLs, and validation activities
- •Review clinical study reports, manuscripts, and other statistical documentation
- •Review clinical protocols and develop statistical sections, including study design elements, sample‑size calculations, and analysis methodologies
- •Review CRFs, database structures, edit‑check specifications, and data‑collection elements to ensure statistical adequacy
- •Develop and/or review Statistical Analysis Plans (SAPs), TFL shells, and derivation specifications
- •Collaborate with Statistical Programmers and Data Management to identify and resolve data‑quality issues for key efficacy and safety endpoints
- •Support regulatory submissions, including preparing responses to health‑authority questions and executing additional analyses as required
- •Provide leadership and oversight to CRO statisticians and statistical programmers, ensuring high‑quality deliverables and adherence to timelines
- •Partner effectively with cross‑functional teams including Clinical, Regulatory, Programming, and Data Management
- •Perform additional statistical tasks as needed to support clinical development objectives
- •Lead statistical activities across assigned clinical studies from design through reporting