Director Biostatistics

Sigma-Chiconsulting; Hyderabad, Visakhapatnam; Remoto; INR 4.000.000 - 7.000.000; Tempo pieno

Descrizione del lavoro

Sigma-Chi Consulting, a leading biometrics partner, invites a Director of Biostatistics to Hyderabad/Visakhapatnam or remote. You will set statistical strategy for sponsor programs, build and mentor a high-performing biostatistics team, and drive scientific direction across studies and submissions.

We seek an PhD or MSc in Statistics/Biostatistics with 12+ years in clinical biostatistics, proven leadership, and strong regulatory submission experience.

Competenze

• PhD or MSc in Statistics or Biostatistics.
• 12+ years in clinical biostatistics in pharma/biotech/CRO.
• Proven leadership and regulatory submission experience.
• Expert knowledge of ICH E9 / E9(R1), estimands, CDISC ADaM.

Mansioni

• Provide statistical leadership on study design, sample size and analysis strategy
• Oversee deliverables and ensure quality across studies and submissions
• Represent Sigma-Chi in sponsor meetings and regulatory interactions
• Hire, develop biostatisticians and collaborate with programming and data management

Conoscenze

Biostatistics leadership

Strategic thinking

Stakeholder communication

Team building

Regulatory submissions

Formazione

PhD or MSc in Statistics/Biostatistics

Strumenti

SAS

R

Descrizione del lavoro

With more than a decade of experience, Sigma-Chi Consulting is a trusted biometrics partner to pharmaceutical and biotech sponsors, with teams in Hyderabad and Visakhapatnam supporting clients in the USA and Europe. We deliver biostatistics, statistical programming, clinical data management and AI-driven TLF quality control, with a strong focus on quality and on-time delivery.

Location: Hyderabad / Visakhapatnam, India, or remote

Job Overview

As Director, Biostatistics you will lead our biostatistics function, set statistical strategy for sponsor programs and grow a high-performing team of statisticians.

Key Responsibilities

• Provide statistical leadership on study design, sample size and analysis strategy
• Author and review protocols, statistical analysis plans and clinical study report sections
• Oversee statistical deliverables across studies and submissions for quality and timelines
• Represent Sigma-Chi in sponsor meetings and, when needed, regulatory interactions
• Lead, hire and develop biostatisticians and work closely with programming and data management
• Help shape our service offerings, SOPs and new methods, including AI-assisted QC

Requirements

• PhD or MSc in Statistics, Biostatistics or a related field
• 12+ years of experience in clinical biostatistics within pharma, biotech or a CRO
• Proven record of leading teams and supporting regulatory submissions
• Expert knowledge of ICH E9 / E9(R1), estimands and CDISC ADaM
• Excellent communication with sponsors and senior stakeholders

Good to have

• Experience with adaptive or Bayesian designs
• Oncology or vaccine program experience
• Programming skills in SAS and R

What we offer

• A senior leadership role in a growing biometrics company
• Direct impact on our scientific direction and team