YEARS OF EXPERIENCE: 8 to 10 plus years as a Biostatistician in a regulated medical, pharmaceutical, or related industry. 2-3 years of Oncology TA Experience is preferred.
EDUCATION: Masters degree in Statistics, Bio statistics or relevant.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Responsible for performing protocol review and providing inputs.
Works with project team to decide on appropriate study design and statistical
methodology for routine designs.
Assists in the development of randomization schedule, sample size and power
Responsible for making statistic model selection, experimental design, design and analysis of clinical trials
Analyze and interpret data from individual trials. Perform meta-analyses by pooling data from several studies
Writes and reviews Statistical Analysis Plans (SAPs) based on the protocol, including development of well-presented mock-up displays for tables, listings, and figures in collaboration with sponsor.
Participates in project teams as Biostatistics representative, interfacing as necessary with other departmental project team representatives.
Creates or reviews programming specifications for analysis datasets, tables, listings, and figures.
Participates in DSMB and/or DMC activities, including charter development and serving as an independent statistician.
Conducts and participates in reviewing and performing quality control of project deliverables, ensuring that output meets expectations and is consistent with analysis described in SAP.
Ensures proper study conduct, IAs and closeout by documenting and archiving study related materials according to Standard Operating Procedures (SOPs), and/or sponsor instructions.
SPECIALIZED KNOWLEDGE AND SKILLS:
Experience in analysis and presentation of clinical data
Strong problem-solving skills
Experience with SAS/STAT, the SAS Macro language, SAS/GRAPH and the SAS Output Delivery System (ODS) required
Strong DATA step programming skills
PROC REPORT familiarity and the handling of coding dictionaries preferred
Experience with design and analysis of clinical trials
Founded in 2006, Synowledge specializes in providing drug safety, regulatory affairs and... related IT services to small, mid, and large sized pharmaceutical, biotechnology and medical device companies. We are headquartered in Stamford CT, USA with operational facilities across the United Kingdom, Columbus, Ohio, and Bangalore, India. Our comprehensive outsourcing solutions combine the unique strengths of both onshore and offshore services to meet all of our clients’ pressing needs.
Read full description