Biostatistician - Bengaluru, India - Sitero LLC

Sitero LLC

Verified Company

Bengaluru, India

3 weeks ago

Posted by:

Deepika Kaur

beBee Recuiter

Description

Biostatistician - Job Description
Sitero is an emerging leader in Clinical services and software solutions for the life sciences
industry. We have experience and expertise in a diverse range of therapeutic areas and focus on
innovative, technology-enabled solutions that allow our clients to focus on their core strengths.
For early phase studies through Phase III clinical trials, our experienced team delivers high-touch
services and technology to ensure the safety of all stakeholders across the clinical research
community with an emphasis on ethics, compliance, and innovation.

ESSENTIAL DUTIES AND RESPONSIBILITIES

You would be responsible for:

Strong understanding of statistical principles and strong statistical skills, provide

statistical support to clinical studies

Performing statistical analyses of clinical data, interpreting statistical results of drug

molecule / study goal on efficiency and safety.

Experience in sample size calculation, protocol concept development, protocol

development, SAP and preparing clinical study reports including integrated summaries

for submissions.

Solid understanding & implementation of CDISC requirement for regulatory submissions.
Experience in STDM, ADaM specifications generation and QC of datasets.
Knowledge of SAS programming and R programming with 3+ years of experience in

leading team and working in a CRO/Pharma/Biotech company

Proficient in BASE, STAT, MACRO and GRAPH and understanding of database structures,

TLFs proficiency

Solid project management skills, as shown through management of multiple projects
Demonstrated initiative and motivation
Strong written and verbal communications skills, including proficiency in the English

language

Capable of directing and promoting teamwork in a multidisciplinary team setting
Excellent written and verbal communications
Strong knowledge of ICH guidelines.
Uses SAS or other software to develop custom programming code to generate summary

tables, data listings, graphs and derived datasets as specified in the statistical analysis

plan and programming specifications.

Creation and updating SOPs

EDUCATION AND EXPERIENCE REQUIRED

MSc or PhD in Biostatistics or Statistics
5+ years of experience as Biostatistician and working in a CRO/Pharma/Biotech company
Strong written and verbal communications skills, including proficiency in the English

language

Capable of directing and promoting teamwork in a multidisciplinary team setting
Excellent written and verbal communications
Coach/mentor new team members to support efficient and quick onboarding
Cross functional collaboration & Stakeholder management
Strong knowledge of ICH guidelines.

COMPENSATION & BENEFITS
Sitero proudly offers an impressive compensation package and benefits, including a competitive
salary, Variable pay, paid time off, and healthcare and retirement benefits.

EMPLOYMENT TYPE
Full Time, Permanent

COMMITMENTS