Clinvia

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Career

Clinvia LLC is a global data science consulting company exclusively dedicated to providing Technology and Data Science services to pharmaceutical, biotechnology and Medical Devices industries. We are looking for passionate candidates who can help make a difference. If you have the education, experience, skills, and dedication to work for a high-performance organization, then we want to hear from you.

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Open positions

  • Sr/Principal Biostatistician
  • Principal Statistical Programmer

Clinvia offers excellent compensation and benefits packages to employees.   Come join us and become part of a dynamic team that is making a difference in healthcare by bringing new and better medicines to people suffering from Diabetes and Cancer.

Job description

1. Sr/Principal Biostatistician
  • Clinvia Flexible Solutions Program (FSP) offers statistical programmers, biostatisticians and clinical data specialists amazing opportunities to work on client projects supporting clinical trial design and analysis.

The Principal Biostatistician within FSP will provide statistical and development support and influence for the associated client's trials providing expertise into processes, clinical development plans, concept sheets and protocols as well as potentially providing oversight of work supported by other vendors. You will understand complex and critical business problems from a client's country/regional/global business functions, formulate integrated analytical approach to mine data sources, employ statistical methods, machine learning & deep learning algorithms to discover actionable insights and automate process for reducing effort and time for repeated use. High agility to be able to work across various business domains and divisions. Able to use business presentations, impactful visualization of ML results and contextual storytelling to translate findings back to business users with a clear impact.

Responsibilities include but are not limited to:

  • Provide statistical input into study protocols, Case Report Forms, and data management plans, DSMBs and write statistical analysis plans, review or create analysis dataset specifications, and perform statistical analyses.
  • Longitudinal data/analysis.
  • Provide statistical output as required for manuscripts and ensures that the results are accurately interpreted in the publications.
  • When in the Lead Biostatistician role for a project: manage biostatisticians and statistical programmers with respect to statistical strategy, deliverables and processes.
  • Generate the use of innovative statistical methodology approaches by identifying, adapting, developing or using optimal statistical research methodologies and techniques appropriate to each project, and contribute internally and externally to the development and visibility of the company and of the Clinical Services department through her/his expertise and customer orientation.
  • Develop strong collaboration and communication with sponsor cross-functional teams and sponsor Biostatistics management.
  • Ability to work independently, demonstrate initiative and flexibility through effective and innovative leadership. Attention to detail and quality focused, excellent interpersonal and communication skills, innovative, and collaborative behaviors & strong “can-do” orientation.
Qualifications and Experience:
  • PhD in statistics or Master's degree in statistics or related subject required along with clinical trial experience.
  • Relevent experience in statistical or biostatistical analysis supporting clinical trial operations for the pharma/biotech industry preferred.
  • Excellent verbal and written communications skills.
  • Ability to organize multiple work assignments and establish priorities.
  • Working SAS & CDISC knowledge required.
2. Principal Statistical Programmer
  • Work with one of our preferred clients! Our client is a leading pharmaceutical/biotech company dedicated to advancing medical science and improving patient outcomes through the development of innovative therapeutics. Their research-driven organization focuses on discovering, developing, and commercializing novel drugs across various therapeutic areas. We are seeking a highly skilled and motivated Principal Statistical Programmer with expertise in CDISC and submission to join our dynamic FSP team.

    Position Overview: As a Principal Statistical Programmer you will play a pivotal role in the design, execution, and analysis of clinical trials to support the development of our promising drug candidates. Leveraging your extensive knowledge of statistical programming and CDISC principles, you will collaborate closely with cross-functional teams of scientists, clinical researchers, and biostatisticians to ensure the successful implementation of our clinical development programs.
Responsibilities include but are not limited to:
  • CDISC SDTM and ADaM data analysis using appropriate statistical methodologies to support clinical trial designs and assist in decision-making processes.
  • Statistical Programming: Develop and implement robust and efficient statistical programming solutions for creating SDTM, ADaM datasets, adhering to industry best practices and regulatory standards. Generate and validate TLF’s.
  • Protocol Development: Provide valuable input during protocol development, ensuring proper incorporation of CDISC standards and statistical methodologies.
  • Clinical Trial Support: Collaborate with cross-functional teams to ensure the timely and accurate delivery of PK/PD data analysis for ongoing clinical trials, supporting data interpretation and presentation.
  • Regulatory Submissions: Contribute to regulatory submissions by preparing and validating TLF’s analysis outputs, and documentation in compliance with relevant regulatory guidelines.
Qualifications and Experience:
  • Master's or Ph.D. in Biostatistics, Statistics, or a related field with five year experience a strong emphasis on CDISC standards.
  • Substantial experience in statistical programming using SAS, R, or other relevant programming languages within the pharmaceutical or biotech industry.
  • Proven expertise in SDTM and ADaM dataset specification and programming including TLF’s programming .
  • Solid understanding of clinical trial designs, protocols, and regulatory requirements related to oncology submission.
  • Familiarity with industry standards such as CDISC data structures and guidelines for data submissions.
  • Strong analytical, problem-solving, and communication skills, with the ability to work effectively in cross-functional teams.
  • Detail-oriented with a commitment to producing high-quality deliverables within tight timelines.

Lets talk about your project

Office Address

2500 Regency Pkwy, Cary,
NC 27518

Phone Number

+1 408-540-3127

Email

info@clinvia.com

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Apply now!

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