Sitero - Biostatistician - Clinical Data Management

1 month ago

Bengaluru, India SITERO SOLUTIONS INDIA PRIVATE LIMITED 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, 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 acrossthe clinical research community with an emphasis on ethics, compliance, and innovation.


Job Title : : Bangalore Office Based (Hybrid Model)


Function :


ESSENTIAL DUTIES AND RESPONSIBILITIES :


You would be responsible for :


- Statistical Expertise : Possess a strong understanding of statistical principles and demonstrate strong statistical skills. Provide comprehensive statistical support throughout clinical studies.


- Statistical Analysis and Interpretation : Conduct statistical analyses of clinical data and interpret the results,

focusing on the efficiency and safety of drug molecules or study goals.


- Study Design and Reporting : Experienced in calculating sample sizes, developing concepts and protocols for studies, creating Statistical Analysis Plans (SAP), and preparing clinical study reports, including integrated

summaries for regulatory submissions.


- Regulatory Engagement : Engage with regulatory bodies such as the FDA and EMEA, preparing statistical

documentation and effectively communicating statistical plans and results in professional forums.


- DMC/DSMB Support : Provide support for Data Monitoring Committees/Data Safety Monitoring Boards

(DMC/DSMB), including charter development, SAP, and mock Tables, Listings, and Figures (TLFs) for DSMB

support. This encompasses interim analysis, TLF shells, both blinded and unblinded reports, and organizing

kick-off meetings.


- Regulatory Submission Standards : Solid understanding and implementation of Clinical Data Interchange

Standards Consortium (CDISC) requirements for regulatory submissions, including experience with Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) specifications generation and quality control of datasets.


- SAS Proficiency : Extensive hands-on experience in statistical analysis using SAS, including creating mock shell for tables, listings, and figures (TLFs), and validating TLFs for New Drug Applications (NDA) and Biologics

License Applications (BLA) submissions.


- Client Interaction and Sales Support : Actively engage with clients to understand their statistical and analytical needs, providing expert advice and solutions. Support the sales cycle by contributing to proposals,

presentations, and discussions that showcase our statistical capabilities and how they meet SOP Development : Responsible for the creation and updating of Standard Operating Procedures (SOPs)

related to statistical processes and regulatory submissions.


JOB DESCRIPTION :


Company Proprietary & Confidential 2


EDUCATION AND EXPERIENCE REQUIRED :


- MSc or PhD in Biostatistics or Statistics


- 10+ years of experience as Biostatistician and working in a CRO/Pharma/Biotech company


- 3+ years of experience in leading team of biostatisticians and statistical programmers and working in

a CRO/Pharma/Biotech company


- Strong written and verbal communications skills, including proficiency in the English language with

the ability to explain complex statistical concepts to non-statisticians


- Proficient in statistical programming languages such as SAS, R, or Python.


- Proficient in BASE, STAT, MACRO and GRAPH and understanding of database structures, Capable of directing and promoting teamwork in a multi-disciplinary team setting


- Strong knowledge of regulatory guidelines and statistical methodology related to 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.


PREFERRED SKILLS :


- Good written and verbal communication skills.


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.


DISCLAIMER :


Sitero is an equal opportunity employer and welcomes all job applicants. All qualified applicants will receive

consideration for employment without discrimination on the basis of race, color, religion, sex, sexual

orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law

(ref:hirist.tech)

  • Senior Clinical Biostatistician

    3 weeks ago

    Bengaluru, Karnataka, India SITERO SOLUTIONS INDIA PRIVATE LIMITED Full time

    Unlock a career in clinical data analysis with Sitero Solutions India Private Limited as a Senior Clinical Biostatistician. Our team is dedicated to delivering high-quality services and software solutions for the life sciences industry.We are seeking an experienced professional to join our Bangalore office based (hybrid model) team. As a Senior Clinical...

  • Biostatistician

    6 months ago

    Bengaluru, Karnataka, 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...

  • Biostatistician - Clinical Data Management

    2 weeks ago

    Bengaluru, India Ivanan Consultancy Services Inc 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...

  • Edc Study Programming Associate

    8 months ago

    Bengaluru, India Sitero LLC Full time

    **Company Overview**: Sitero is a leading organization specializing in clinical research and healthcare solutions. We are dedicated to advancing medical research and improving patient outcomes through innovative technologies and services. As we continue to grow, we are seeking a highly motivated and detail-oriented EDC Study Programming Associate to join...

  • Database Administrator

    6 months ago

    Bengaluru, India Sitero LLC Full time

    **Database Administrator** - Job Description** Sitero Clinical Research is a full-service CRO that provides comprehensive services to guide you through the development and execution of clinical programs across all stages of development and life cycle management. At Sitero we offer experience and expertise with a diverse range of therapeutic areas and focus...

  • Database Administrator

    6 months ago

    Bengaluru, Karnataka, India Sitero LLC Full time

    Sitero Clinical Research is a full-service CRO that provides comprehensive services to guide you through the development and execution of clinical programs across all stages of development and life cycle management. At Sitero we offer experience and expertise with a diverse range of therapeutic areas and focus on innovative, technology-enabled solutions...

  • Cloud Architect

    6 months ago

    Bengaluru, India Sitero LLC Full time

    **Cloud Architect** - Job Description** Sitero Clinical Research is a full-service CRO that provides comprehensive services to guide you through the development and execution of clinical programs across all stages of development and life cycle management. At Sitero we offer experience and expertise with a diverse range of therapeutic areas and focus on...

  • Talent Acquisition Associate

    6 months ago

    Bengaluru, Karnataka, 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...

  • Senior Biostatistician

    7 days ago

    Bengaluru, Karnataka, India IQVIA Full time

    About the Role:IQVIA is seeking a highly skilled Senior Biostatistician to join our team. As a key member of our clinical trials group, you will be responsible for leading the statistical analysis and reporting of complex clinical trials.Key Responsibilities:Lead the development of Statistical Analysis Plans (SAPs) and ensure compliance with Good Clinical...

  • Ui/ux Designer

    3 months ago

    Bengaluru, Karnataka, 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...

  • Biostatistician

    3 months ago

    HSR Layout, Bengaluru, Karnataka, India Clini launch Research Institute Full time

    **Job Title: Biostatistician (Fresher)** **Location**: [Insert Location] **Company**: [Insert Company Name] **Job Type**: [Full-time/Part-time/Internship] **About Us**: CliniLaunch Research Institute stands as an IAO, LSSSDC, and NSDC accredited and certified institution specializing in healthcare upskilling and comprehensive placement assistance....

  • Clinical Trials Biostatistician cum Statistical Programmer Associate Manager

    2 weeks ago

    Bengaluru, Karnataka, India Biocon Biologics Full time

    Biostatistician cum Statistical ProgrammerWe are seeking a highly skilled Clinical Trials Biostatistician cum Statistical Programmer to join our team as an Associate Manager. In this role, you will be responsible for performing biostatistical and SAS programming activities for various clinical trials involving novel, biosimilar, and PMS studies.About the...

  • Principal Biostatistician

    1 month ago

    Bengaluru, Karnataka, India Icon plc Full time

    Principal Biostatistician, Office or Home, India ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development We are currently seeking a Principal...

  • Clinical Data Management Statistician Lead

    7 days ago

    Bengaluru, Karnataka, India Ivanan Consultancy Services Inc Full time

    Job SummaryWe are seeking a highly experienced Biostatistician to lead our clinical data management team. The successful candidate will be responsible for providing statistical expertise and support throughout clinical studies, from study design and protocol development to analysis and interpretation of results.This is an excellent opportunity for a talented...

  • Biostatistician Ii

    2 weeks ago

    Bengaluru, Karnataka, India Parexel Full time

    The **Biostatistician II** works independently in the programming and quality control of derived datasets and all kind of statistical outputs (eg, tables, listings and figures), works under the supervision of an experienced biostatistician in the production of analysis plans and reports, provides basic statistical advice to clients and fulfils the project...

  • Biostatistician Ii

    3 months ago

    Bengaluru, Karnataka, India Parexel Full time

    The **Biostatistician II** works independently in the programming and quality control of derived datasets and all kind of statistical outputs (eg, tables, listings and figures), works under the supervision of an experienced biostatistician in the production of analysis plans and reports, provides basic statistical advice to clients and fulfils the project...

  • Biostatistician Ii

    8 months ago

    Bengaluru, Karnataka, India Parexel Full time

    Job Purpose: The Biostatistician II works independently in the programming and quality control of derived datasets and all kind of statistical outputs (eg, tables, listings and figures), works under the supervision of an experienced biostatistician in the production of analysis plans and reports, provides basic statistical advice to clients and fulfils the...

  • Accounts Associate

    6 months ago

    Bengaluru, India Sitero LLC Full time

    **Job Title: Accounts Associate - Receivable** **Location: Bangalore/Hybrid** **Function: Finance Department** **DESCRIPTION**: Accounts Receivable Associate is responsible for preparing accounts receivable transactions and processes customer payments. Responsible for creating invoices according to company practices and submit them for approval by...

  • Biostatistician Consultant

    2 weeks ago

    Bengaluru, Karnataka, India Lilly Full time

    We're seeking a Senior Principal Biostatistician with a strong scientific mindset to join our team.About the RoleThis role is focused on developing and implementing statistical methods for clinical trials, collaborating with cross-functional teams, and providing expert analysis to support regulatory submissions.Key Responsibilities:Design and develop...

  • Biostatistician

    6 months ago

    Bengaluru, Karnataka, India ClinChoice Full time

    ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative "one-team" culture. We are looking for a dynamic person to join our in-house team as a Principal Biostatistician on a permanent basis. You will work on projects from our varied client base, ranging...