Senior/principal Biostatistician

3 weeks ago


Oxfordshire, United Kingdom Hyper Recruitment Solutions Ltd Full time

We are currently looking for a Senior/Principal Biostatistician to join a leading Biopharmaceutical company based in the Oxfordshire area. As the Senior/Principal Biostatistician you will be responsible for supporting Biostatistics activities on assignedClinical Development, Enterprise Data & Analytics, and QDS projects, including contributions to milestone planning and delivery, data and knowledge stewardship, and inspection readiness.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Senior/Principal Biostatistician will be varied however the key duties and responsibilities are as follows:
1. Oversee the statistical design, analysis and interpretation of early and late phase clinical trials including biomarker analyses and integrated analyses across trials.
2. Deliver and QC tables, listings and figures for clinical study reports, conferences/ publications, safety reviews and regulatory requests.
3. Lead statistical contributions to the design of clinical studies; authoring statistical elements of clinical study protocols; performing sample size calculations; creating study randomizations and authoring of statistical analysis plans.
4. Independently research and program statistical methodologies.
ROLE REQUIREMENTS:
1. Postgraduate degree in Statistics or related discipline with a minimum of 3 to 5 years in a pharma/ biotech/ CRO environment.
2. Extensive programming experience using SAS.
3. Expert knowledge and experience in clinical drug development, study and program design, clinical data integration, analysis and interpretation, regulatory submission and authority interactions.
Key Words: Senior, Principal, Biostatistician, Biostats, Clinical, Biopharmaceutical, Oncology, Statistics, Statistical, SAS, STDM, ADaM ,


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