Senior Biostatistician

Redbock

(remote)

JOB DETAILS
SALARY
$80–$120 Per Hour
JOB TYPE
Contractor
SKILLS
Biostatistics, Clinical Trial, Statistics, Analysis Skills, Clinical Data, Computer Programming, Consulting, Contract Management, Contract Research Organization (CRO), Cross-Functional, Data Analysis,
QUALIFICATIONS
  • PhD in Biostatistics/Statistics or related field and at least 4+ years of biostatistics experience in pharma (Small to mid-sized companies) OR MS in Biostatistics/Statistics or related field and at least 7+ years of pharma experience
  • Must have Multiple Imputations experience (MI)
  • Must possess strong statistical programming technical expertise in SAS
  • Recent submissions experience - preferable to have experience in Phase III and late phase clinical trials
  • Experience providing CRO/vendor oversight, ensuring deliverables and timelines are being met
RESPONSIBILITIES
  • Contribute to study design, protocol development, sample size calculation, CRFs, Results Interpretation, clinical study report, and addressing questions from regulatory agencies.
  • Collaborate with vendor to develop and maintain SAPs, including the derived variables, the templates of statistical TFLs
  • Provide guidance to the study team for all statistical activities while collaborating with a data manager to ensure high-quality data
  • Work collaboratively with cross functional teams to ensure timelines are being met
  • Manager CROs by establishing procedures through regular interaction, setting expectations on deliverables and timelines to guide vendor biostatisticians and statistical programmers
  • Provide input for regulatory interaction or by writing the interaction document; may participate in meeting or teleconferences with Health Authorities
  • Coordinate with all team members to prepare the statistical analyses for IB, DSUR update, periodic safety updates, and other ad hoc safety analyses; participate in cross-functional study-related activities, attend team meetings
BENEFITS
Work From Home, 401K, Medical, Dental, Vision
POSTED
8 days ago

This consultant will be supporting statistical activities for clinical trials such as contribution to trial designs, authoring statistical sections of protocols, preparing SAPs, and reviewing and interpreting the analysis of clinical trial data. They will also interact with internal and external cross-functional study teams, supporting interactions with Health Authorities globally, and manage contract research organization (CRO) programmers and statisticians in preparing analysis files and performing statistical analyses.

About the Company

R

Redbock

Redbock is a specialized life sciences consultancy that delivers customized resourcing solutions to pharmaceutical, biotechnology, medical device and diagnostics companies. We provide expert solutions to resource-challenged companies, and positively impact the lives of the consultants helping them.

Over the years, our consultants have brought solutions to some of the largest, high-profile companies in the industry. We specialize in quality assurance, regulatory and compliance, engineering, clinical operations, and biometrics.

Redbock is now a part of NES Fircroft - an award winning workforce solutions company, that provides candidates across the Life Sciences, Energy, Construction/Infrastructure, Manufacturing, Chemicals, Mining and IT sectors. 

 

HEADQUARTERS
Encinitas, CA, US
INDUSTRY
Biotechnology/Pharmaceuticals
FOUNDED
2010