FREELANCE: Senior Biostatistician

FREELANCE: Senior Biostatistician 

| 6 months contract | UK/Europe

Jonathan Cunliffe at Umbilical has partnered with a growing CRO for an experienced Biostatistician to consult on multiple and complex studies as well as the independent Statistician when required.

Accountable for:

As lead Statistician you will;

• Author the Statistical Sections of Protocol.
• Propose and Review the Study design.
• Calculate the sample size.
• Review the Edit Check Document (specifically for critical modules like RECIST 1.1 etc.).
• Write the randomization specifications and coordinate and finalize all the randomization activities with the IWRS vendor.
• Author Statistical Analysis Plan (interim and final as appropriate).
• Perform the Statistical Analysis (Efficacy and Safety (key safety like Adverse Events)) using SAS.
• Provide Statistical Consultancy on an ongoing basis for projects.
• Perform Futility and Efficacy analysis as appropriate for interim analysis and interact with third party independent Statistician.
• Defend the Statistical Analysis at the IDMC meetings as appropriate.
• Write the specifications for the efficacy analysis. Review the Specifications for the Safety Analysis.
• Organize Data Review Meetings (equivalent to Blinded Data Review (BDR) or Dry Run) and lead all the statistical discussions.
• Work Collaboratively with the data management, Clinical Operations, Medical Writing and the Pharmacovigilance team as appropriate.
• Provide inputs to the regulatory affairs for all the discussions with the health authorities (e.g. ANSM, EMA, FDA).
• Perform exploratory analysis as appropriate

Qualifications:

Educated to PhD/Masters in Statistics, Biostatistics or related subject with high statistical content;

• 3+ years continuous and up to date experience as a Statistician in the Pharmaceutical or CRO industry
• Knowledge of various statistical methods and their application.
• Expert statistical (SAS) programmer with knowledge of R.
• Analytic, problem-solving, and critical and creative thinking skills
• Excellent attention to detail, teamwork and initiative, with flexibility to adapt to the needs of the organization; maintain meticulous attention to project deadlines
• Excellent written and verbal communication and interpersonal skills

For a confidential discussion, contact Jonathan Cunliffe at Umbilical

Reference ID: 

Contract length: 6 months, good chance to be extended

Job Types: Full-time, Contract