Senior Biostatistician

Company: Cytel Inc
Location: South Bend
Posted on: July 17, 2021

Job Description:

Cytel provides unrivaled biostatistics and operations research knowledge to our customers in the life sciences industries in the form of both software and services.  At Cytel, we work hard to create successful careers with significant professional growth for our employees, as a result of which they work hard to make Cytel successful. Cytel is a place where talent, experience and integrity come together to advance the state of clinical development.

As Senior Biostatistician, adapt at utilizing advanced statistical methods, you will support or lead one or more Phase I-IV clinical studies, with a focus on Neurological Disorders

You will contribute by:

• providing statistical support to clinical studies, with a focus on Neurological Disorders (Multiple Sclerosis, HIV, Alzheimer’s, Strokes, etc.);
• participating in the development of study protocols, including participation in study design discussions and sample size calculations;
• reviewing CRFs and data review guidelines; developing statistical analysis plans (SAPs), including analysis dataset and TLG specifications;
• performing statistical analyses;
• interpreting statistical results;
• preparing clinical study reports, including integrated summaries for submissions;
• leading study activities when called upon;
• utilizing your strong communication skills to present and explain methodology and consequences of decisions in lay terms;
• serving as a team player, with a willingness to go the extra distance to get results, meet deadlines, etc.;
• being adaptable and flexible when priorities change

Qualifications:

• MSc or PhD in a statistical field
• 5+ years of relevant clinical trial biostatistics support in design, analysis and interpretation. Proven experience of work with clinical trial data in support of safety and efficacy analysis.
• Knowledge and strong experience in survival analysis, linear and generalized linear models. . Capacity to interface effectively with clinicians and statistical programmers
• Capacity to work independently or under the guidance of a more senior statistician
• Capacity to quickly read late development protocols, to understand the statistical methodology and to apply to clinical data
• Knowledge aqd practice of CDISC SDTM and ADaM data standards
• Ability to work complying to the company Analysis and Reporting SOPs and project data standards
• Fast learner, team oriented, able to work independently
• Ability to read, write and speak fluently in English
• Knowledge of SAS programming SAS/STAT SAS/BASE, SAS macro language
• Experience with SAS on PC and UNIX platforms.

Cytel Inc. is an Equal Employment / Affirmative Action Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law.

Cytel does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Cytel’s human resources department to obtain prior written authorization before referring any candidates to Cytel. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and Cytel. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of Cytel. Cytel shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies.

Keywords: Cytel Inc, South Bend , Senior Biostatistician, Other , South Bend, Indiana