Principal/Senior Manager Biostatistician Clinical Trials

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. 

Onsite | No Visa Sponsorship | 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)