Bio Statistician

5 days ago

Bengaluru, India Sitero LLC Full time

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:

- Provides statistical support for clinical studies, including study design, sample size calculations, patient randomization, statistical analyses, interpretation of data, and reporting of results.
- 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 and Strong knowledge of ICH guidelines.
- 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
- 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 or related discipline.
- 7+ 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

**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 needed.

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