Statistician / Biostatistician / Bioinformatician

Position: Statistician / Biostatistician / Bioinformatician

Location: 100% (Remote)

Type: Contract Long Term

Experience Level: 12+ (Atleast 6+ relevant exp is also fine)

Pay Rate: $40/hr on W2 (Can give couple of $ upon good profile)

Except CPT & OPT any Visa is fine

Key Requirements:

•who worked on Clinical trials with BioPharma, MedTech company or CRO

•who can support as independent statistician on IA/DMC.

Skills

• • Provides statistical and methodological consultation and contributes to multi-disciplinary and multi-company teams.

• • Provide statistical support for case report form design, database development, data validation plan and blinded data review as and when required.

• • Support and lead DMC/IA activities as blinded or unblinded Statistician and lead programming team as per requirement

• • Development of Statistical Analysis Plan (or equivalent) including table shells design.

• • Perform statistical programming to generate tables, listings, figures, and statistical analysis.

• • Conduct literature searches to support statistical analysis.

• • Comply with project / trial standards and specifications following internal guidelines as well as the guidelines set by the various health authorities.

• • Responds to inquiries from health authorities and other internal or external partners and participates in client or regulatory audits.

• • Contribute to clinical trial result interpretation and facilitate discussions on the same.

• • Guide cross functional teams – Data management and medical writers for all trial related activities

Qualifications and/or Experience

• • PhD or MS in Biostatistics, Statistics or Mathematics

• • At least 6+ years of experience as statistician with significant time spent in the Pharma, Biotech, or similar sector

• • Thorough knowledge of the pharmaceutical or Medical devices industry including understanding of clinical drug development process and associated documents and regulations.

• • Experience in leading teams

• • Excellent interpersonal, leadership and communication skills and ability to work independently and collaboratively as required

• • Good knowledge of statistical programming languages (including SAS)