Principal Biostatistician

4 weeks ago

Bengaluru, India Thermo Fisher Scientific Full time

We are seeking independent thinkers with problem-solving skills and a quality focused mindset to join our award-winning and supportive global team on an exciting clinical research adventure.

The PPD Biostatistics & Programming environment is structured to ensure focus and development in key areas of interest. Our working model revolutionizes delivery through aligned and focused pillars which drive in-depth knowledge and enhanced coaching. We offer continued career advancement opportunities and comprehensive training to help you reach your full potential and develop your own unique career path within PPD, part of Thermo Fisher Scientific

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner, and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development, and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.

At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and wellbeing of our employees.

**Summarized Purpose**:
**Essential Functions**:

- Provides expert knowledge within the department on statistical and regulatory issues, mentors members of the department and provides project guidance and statistical advice. Provides expert knowledge and experience of complex trials design across different therapeutic areas.
- Provides expertise in the development and delivery of training material, and the implementation of departmental procedures for the team. Contributes to process improvement and departmental initiatives.
- Serves as senior reviewer on simple or moderately complex studies as assigned with mínimal oversight, and on more complex studies as assigned with supervision as needed.
- Serves as a lead statistician on multiple projects and leads project teams for multiple protocols. Conducts team meetings, maintains project timelines, assesses resource need, provides resources, and budget management. Ensures that SOPs are being followed and that appropriate project documentation is ongoing. Provides management with timely, accurate status and resourcing reports. Allocates and coordinates resources within the team to achieve timelines, time management of own and team's time spent on projects.
- Interacts with the sponsor on statistical aspects of the project and present at meetings as required.
- Produces sample size calculations. Provides input into study design and statistical considerations, during protocol development. Review protocols for completeness, appropriateness of clinical design and sound statistical analysis. Contributes to writing appropriate protocol sections.
- Leads the development and review of statistical analysis plans, including table, listing and graph specifications. Organizes the production of statistical analyses and statistical appendices, with appropriate documentation. Ensures that appropriate validation for statistical analyses and statistical appendices is implemented.
- Specifies the general structure of the analysis database, oversees its development, and ensures completeness for use in all programming.
- Oversees the preparation and quality review of statistical reports, integrated summaries of safety, integrated summaries of efficacy and other documents, as required. Contributes statistical methods section for integrated clinical statistical reports.
- Provides input to management as to hiring recommendations, department policies, and resourcing requirements.
- Acts as the representative of the department to other divisions.
- Assists in bidding and business development activities, as required.

**Education and Experience**:
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 6+ years’). Master's degree in statistics, biostatistics, mathematics or related field

Extensive experience of statistics in a clinical trial environment. Evidence of providing expert statistical input in previous positions and presenting at statistical conferences would be an advantage.

In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

**Knowledge, Skills and Abilities**:

- Excellent understanding of t

  • Principal Biostatistician

    4 days ago

    Bengaluru, Karnataka, India ICON plc Full time

    Job DescriptionPrincipal Biostatistician, Office or Home, IndiaICON 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 developmentWe are currently seeking a Principal...

  • Principal Biostatistician Fsp

    2 weeks ago

    Bengaluru, Karnataka, India Cytel Inc Full time

    India **and**2** more** **BE THE FIRST TO APPLY** - As a Principal Biostatistician, you are responsible for statistical activities in support of Immunology or Oncology TA group, including study designs, study protocol and analysis plan development, reviewing and interpreting the analysis of study data, and conducting ad hoc and exploratory...

  • Senior / Principal Biostatistician

    3 weeks ago

    Bengaluru, Karnataka, 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...

  • Senior / Principal Biostatistician

    7 days 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...

  • Senior Biostatistician

    3 weeks ago

    Bengaluru, Karnataka, India Parexel Full time

    When our values align, there's no limit to what we can achieve.   Job Description : As an experienced Biostatistician, you will lead research design and analytical strategies, provide input into protocols, develop and review statistical analysis plans and author/co-author reports, abstracts and manuscripts. You will use your knowledge to advise,...

  • Senior Biostatistician Ii 3 Days Left

    12 hours ago

    Bengaluru, Karnataka, India Icon Full time

    We encourage our people to seize the opportunity to bring flexibility innovation and determination to every situation By doing this our people build exciting and rewarding careers deliver results to help bring life-changing medicines and devices to market and maintain ICON s success as an industry leader Full ServiceFull-service roles offer the...

  • Principal Biostatistician

    2 weeks ago

    Bengaluru, India Alcon Full time

    GREAT PLACE TO WORK - CERTIFIED Summary of Position: Designs, plans and executes biostatistical components of plans for research and development projects that establish the conditions essential for determining safety, efficacy, and marketability of pharmaceutical and/or biological products. Uses sound statistical methodology to conduct studies relating to...

  • PRINCIPAL STATISTICAL PROGRAMMER

    3 weeks ago

    Bengaluru, India ACL Digital Full time

    PRINCIPAL STATISTICAL PROGRAMMER (12 – 15 YEARS)LOCATION: ANYWHERE IN INDIAWORK MODE : HybridROLES and RESPONSIBILITIES:Implementation of statistical programming strategy related to innovation in technologies, automation, processes, and standards to maximize efficiencySupport the development and implementation of a programming ecosystem to enable...

  • PRINCIPAL STATISTICAL PROGRAMMER

    3 weeks ago

    Bengaluru, India ACL Digital Full time

    PRINCIPAL STATISTICAL PROGRAMMER (12 – 15 YEARS)LOCATION: ANYWHERE IN INDIAWORK MODE : HybridROLES and RESPONSIBILITIES:- Implementation of statistical programming strategy related to innovation in technologies, automation, processes, and standards to maximize efficiency- Support the development and implementation of a programming ecosystem to enable...

  • PRINCIPAL STATISTICAL PROGRAMMER

    3 weeks ago

    Bengaluru, India ACL Digital Full time

    PRINCIPAL STATISTICAL PROGRAMMER (12 – 15 YEARS)LOCATION: ANYWHERE IN INDIAWORK MODE : HybridROLES and RESPONSIBILITIES:Implementation of statistical programming strategy related to innovation in technologies, automation, processes, and standards to maximize efficiencySupport the development and implementation of a programming ecosystem to enable...

  • principal statistical programmer

    2 weeks ago

    Bengaluru, Karnataka, India ACL Digital Full time

    PRINCIPAL STATISTICAL PROGRAMMER (12 – 15 YEARS)LOCATION: ANYWHERE IN INDIAWORK MODE : HybridROLES and RESPONSIBILITIES: Implementation of statistical programming strategy related to innovation in technologies, automation, processes, and standards to maximize efficiencySupport the development and implementation of a programming ecosystem to enable...

  • (High Salary) PRINCIPAL STATISTICAL PROGRAMMER

    4 weeks ago

    Bengaluru, India ACL Digital Full time

    PRINCIPAL STATISTICAL PROGRAMMER (12 – 15 YEARS) LOCATION: ANYWHERE IN INDIA WORK MODE : Hybrid ROLES and RESPONSIBILITIES: - Implementation of statistical programming strategy related to innovation in technologies, automation, processes, and standards to maximize efficiency - Support the development and implementation of a programming ecosystem to...

  • Senior Principal Statistical Programmer

    2 days ago

    Bengaluru, Karnataka, India inVentiv International Pharma Services Pvt. Ltd. Full time

    Statistical Programming Experts at Syneos Health Unlock Your Potential with Syneos Health We are seeking experienced Statistical Programmers to join our dynamic team. If you're passionate about clinical research and data-driven healthcare advancements, this opportunity is for you Open Positions : - Senior Principal Statistical Programmer - Principal...

  • Project Scientist

    2 weeks ago

    Bengaluru, Karnataka, India St. John's Research Institute Full time

    **Brief Description about the Project** **“Project entitled First-1000-Days of Life: Implementation Research for a District Model of Care in Karnataka, India."** This project aims to develop a model improving preconceptional care, care of the pregnant woman, intrapartum care, neonatal care and care of the infant in the first two years to meet the INAP...

  • PRINCIPAL STATISTICAL PROGRAMMER

    4 weeks ago

    Bengaluru, India ACL Digital Full time

    PRINCIPAL STATISTICAL PROGRAMMER (12 – 15 YEARS) LOCATION: ANYWHERE IN INDIA WORK MODE : Hybrid ROLES and RESPONSIBILITIES: Implementation of statistical programming strategy related to innovation in technologies, automation, processes, and standards to maximize efficiency Support the development and implementation of a programming ecosystem to...

  • PRINCIPAL STATISTICAL PROGRAMMER

    4 weeks ago

    Bengaluru, India ACL Digital Full time

    PRINCIPAL STATISTICAL PROGRAMMER (12 – 15 YEARS)LOCATION: ANYWHERE IN INDIAWORK MODE : Hybrid ROLES and RESPONSIBILITIES: Implementation of statistical programming strategy related to innovation in technologies, automation, processes, and standards to maximize efficiencySupport the development and implementation of a programming ecosystem to enable...

  • Senior Principal Statistical Programmer

    1 week ago

    Bengaluru, Karnataka, India inVentiv International Pharma Services Pvt. Ltd. Full time

    Statistical Programming Experts at Syneos Health Unlock Your Potential with Syneos Health We are seeking experienced Statistical Programmers to join our dynamic team. If you're passionate about clinical research and data-driven healthcare advancements, this opportunity is for youOpen Positions :- Senior Principal Statistical Programmer- Principal Statistical...

  • Principal Biostatistician

    2 weeks ago

    Bengaluru, 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

    3 weeks ago

    Bengaluru, Karnataka, India Lilly Full time

    We're looking for people who are determined to make life better for people around the world. Purpose: The Clinical Project Statistician develops or assists in the development of protocol designs, clinical plans, and data analysis plans in collaboration with physicians, veterinarians, and/or medical colleagues. The Clinical Project Statistician is...

  • Senior Principal Biostatistician

    1 week ago

    Bengaluru, India Lilly Full time

    We’re looking for people who are determined to make life better for people around the world. Purpose: The Clinical Project Statistician develops or assists in the development of protocol designs, clinical plans, and data analysis plans in collaboration with physicians, veterinarians, and/or medical colleagues. The Clinical Project Statistician is...