Principal Biostatistician

1w1 week ago

Statistics & Data Corporation (SDC)

Hyderābād, IN · Full-time · INR 3,000,000 – INR 6,000,000

About this role

Statistics & Data Corporation (SDC), a specialized contract research organization headquartered in Arizona, delivers clinical trial services to pharmaceutical and biologic companies since 2005. The Principal Biostatistician applies high-level technical expertise to guide junior biostatistics staff and serve as lead statistician on clinical studies. They maintain statistical and analytical integrity of trials analyzed by SDC.

Daily tasks include writing statistical sections of protocols, preparing statistical analysis plans, and programming summary tables, data listings, and graphs. They perform analyses defined in the plan, including post-hoc and exploratory, while reviewing CRFs for consistency with protocol and SAP. Interpreting results supports clinical study reports and regulatory interactions.

In a collaborative environment, they act as internal consultant and subject matter expert in client and vendor meetings. They manage study budgets, timelines, and expectations, representing biostatistics in sponsor and regulatory meetings. Adherence to SDC’s quality system ensures compliance.

Growth involves developing, coaching, and mentoring junior personnel, contributing to SOPs, and supporting business development with proposals and presentations. This senior role offers strategic planning opportunities in clinical trial success. Participation fosters expertise in technology-enabled services.

Requirements

High level of technical expertise in biostatistics analysis tools and methods
Proficiency in SAS programming for clinical trial data
Experience writing statistical methods sections of protocols and analysis plans
Knowledge of regulatory requirements for clinical studies and FDA interactions
Ability to review CRFs for consistency with protocol and statistical analysis plan
Skills in performing peer review and statistical QC of outputs
Expertise in interpreting clinical trial analysis results

Responsibilities

Serve as lead statistician on clinical research projects and help with SAS programming
Provide statistical expertise for study design of clinical trial protocols
Write statistical analysis plans ensuring appropriate regulatory requirements and study objectives
Program summary tables, data listings and graphical representations of clinical trials data
Perform all analyses defined in the statistical analysis plan including post-hoc analyses
Provide statistical QC of all department outputs including analyses and clinical study reports
Manage biostatistics timelines, budgets, and client expectations
Develop, coach and mentor junior biostatistics department personnel