Job Description

Job Description

Sr. Biostatistician:

· At project level, ensures the study designs are scientifically sound, the efficacy and safety endpoints meets regulatory requirements.

• At study level, provide statistical input to study protocols, develop statistical analysis plan

· Provide statistical support to Clinical Development Plan for multiple compounds

• Assist in writing relevant sections of the clinical study report and publication
• Monitor internal and CRO project activities including timelines, deliverables and resources
• Ability to use SAS to perform efficacy analyses and validate important data derivations when necessary.
• Develop and implement department standards and lead process improvements

· Participate in pre-IND and NDA/BLA activities

Minimum Requirements

• PhD or MS in Biostatistics, Statistics or Applied Math;
• 1 yr experience as statistician in Pharmaceutical or Biotechnology or CRO companies;
• Candidate with Intern experience in the pharmaceutical industry will be considered
• Good knowledge of statistical programming languages (including SAS, R);
• Solid oncology and/or hematology experience
• Experience with advanced study design or at least one NDA/BLA eCTDs or other global regulatory submissions
• Experience as an independent lead statistician with responsibility for multiple studies or projects
• Excellent interpersonal, leadership and communication skills and ability to work independently and collaboratively;
• Knowledge of SDTM/ ADAM

Sr. Statistical Programmer/ SAS Programmer

Major Responsibilities :

• Review a clinical study protocol with regard to statistical programming responsibilities
• Review and provide input to a Statistical Analysis Plan (SAP) and Statistical Programming Plan (SPP)
• Review and provide input to Case Report Forms (CRFs) and external data transfer agreements
• Work cooperatively with and hold accountable clinical study team members including but not limited to the biostatistician, data manager, and medical writer
• Work cooperatively with and oversee a contract programming provider
• Assign tasks, set priorities, and provide technical help to clinical study programming teams
• Develop and maintain SDTM and ADaM specifications
• Program SDTMs, ADaMs, tables, figures, and listings (TFLs) according to approved specifications
• Understand and enforce compliance with programming standards and data standards in clinical study programming teams
• Provide accurate programming time estimates and risk mitigation plans to management or a study team
• Proactively inform management of the status of statistical programming deliverables and issues
• Oversee on-time delivery from clinical study programming teams and meet timelines for multiple concurrent studies
• Contribute to or initiate standards or process improvements

Required Skills:

• Excellent SAS programming skills; contribute programming to a global library of macros
• Able to communicate clearly in oral or written form
• Advanced knowledge of CDISC standards and applying standards to complicated data
• Advanced knowledge of lab data processing and able to resolve issues
• Working knowledge of medical terms, the data coding process, and coding dictionaries
• Apply regulatory agency guidance in statistical programming responsibilities

Preferred Skills:
• Able to program in other languages (e.g. R or S-PLUS, VBA, or Perl)
• Advanced knowledge of Unix commands; able to program shell scripts for complicated tasks
• Advanced knowledge of inferential statistics

Requirements/Qualifications :

Education: Degree with concentration in Life Sciences, Computer Science, Mathematics, Statistics or a quantitative/analytical field.
Experience: A minimum 5 years of SAS programming in clinical studies including leading a clinical study programming team

TechData is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status

Company Description

www.techdataservice.com

Company Description

www.techdataservice.com