Biostatistician

1 week ago

Bengaluru, India Sitero LLC Full time

**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 multi-disciplinary 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 multi-disciplinary team setting
- Excellent written and verbal communications
- Coach/mentor new team members to support efficient and quick on-boarding
- 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**
- Standard Hours 40 hours per week, one hour lunch, Monday - Friday. Additional hours

as needed.
- Willing to work in shifts as and when neede

Sitero Solutions India Private Limited l Address: 120/A Elephant Rock Road, 3rd Block Jayanagar, Bangalore 560011, Karnataka

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