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 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 :


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 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 shells 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 client requirements.


SOP Development :


- Responsible for the creation and updating of Standard Operating Procedures (SOPs) related to statistical processes and regulatory submissions.


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, TLFs proficiency


- Capable of directing and promoting teamwork in a multi-disciplinary team setting


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


- 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 & 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

(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...

  • Senior Biostatistician

    1 week 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...

  • 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....

  • 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 haveexperience 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 IIIclinical trials, our experienced team delivers high-touch...

  • 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

    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 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...

  • 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 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...

  • Clinical SAS Programmer

    3 months ago

    Bengaluru, Karnataka, India Clini launch Business Solutions Full time

    Job Summary We are seeking a skilled and detail-oriented Clinical SAS Programmer to join our team. The Clinical SAS Programmer will be responsible for developing, validating, and maintaining SAS programs for analyzing clinical trial data. The role involves working closely with biostatisticians, clinical researchers, and data management teams to ensure...

  • Biostatistician Ii

    6 months ago

    Bengaluru, Karnataka, India Fortrea Full time

    As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...

  • Senior / Principal Biostatistician

    6 months ago

    Bengaluru, India ClinChoice Full time

    Senior / Principal Biostatistician Full-Time Bengaluru, Karnataka, India Hyderabad, Telangana, India Description Provide statistical oversight to studies and assure adequate quality and consistency with project requirements. Manage activities of statisticians across projects by appropriately coordinating assignments and reviewing work so...

  • Data Analyst and Biostatistician Lead

    3 weeks ago

    Bengaluru, Karnataka, India Lilly Full time

    We are seeking a highly skilled Data Analyst and Biostatistician to lead our team in developing and implementing statistical methodologies for clinical trials.Job DescriptionThe successful candidate will be responsible for:Developing or assisting in the development of protocol designs, clinical plans, and data analysis plans in collaboration with physicians,...

  • Biostatistician

    6 months ago

    Bengaluru, India MOLECULAR CONNECTIONS Full time

    Requirement Details. Designation: Biostatistician Job Location: Remote/ Bangalore Key Tasks - Methodological Support- o Support off-platform implementation of RWD protocols (e.g. drafting protocol sections) for descriptive studies (e.g., drug utilization and natural history of disease studies) and comparative studies (effect estimation)- - o Provide...

  • Senior Biostatistician

    2 weeks ago

    Greater Bengaluru Area, India IQVIA Full time

    Job SummaryWe are seeking a highly skilled Senior Biostatistician to join our team at IQVIA. As a key member of our clinical trials group, you will be responsible for developing statistical methods and leading the execution of studies.About UsIQVIA is a leading provider of data and technology solutions to the healthcare industry. Our team of experts works...

  • Biostatistician

    6 months ago

    Bengaluru, Karnataka, India Merck KGaA Full time

    Work Your Magic with us! Ready to explore, break barriers, and discover more? We know you've got big plans '“ so do we! Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix...