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Job Title : Senior Biostatistician (Publications)
Job Location : United States
Job Location Type : Remote
Job Contract Type : Fulltime
Job Seniority Level : MidSenior level
Job Description
Who Are You
An experienced Biostatistician with a passion for clinical development and analysis adept at utilizing advanced statistical methods you will support or lead one or more Phase IIV clinical studies. You are excited and enthusiastic. You motivate your teams to do great work and collaborate easily with your clients. You never settle for what is but always push clinical development forward to what it could be. You motivate others to do the same.
Sponsordedicated
Working fully embedded within one of our pharmaceutical clients with the support of Cytel right behind you you'll be at the heart of our client's innovation. As a Senior Biostatistician you will be dedicated to one of our global pharmaceutical clients; a company that is driving the next generation of patient treatment where individuals are empowered to work with autonomy and ownership. This is an exciting time to be a part of this new program.
Position Overview
Our Senior Biostatisticians perform adhoc or exploratory analyses to support submission or Health Authority Questions. Having exposure to regulatory work experience is a bonus for example if you understand the regulatory questions and translating them to statistical problems collaborating effectively with clinical and regulatory colleagues. Supporting medium complexity clinical trials (starting from Design to Archival experience) and supporting some projectlevel activities.
Responsibilities
As a Senior Biostatistician your responsibilities will include :
- Providing statistical support to clinical studies
- 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 and interpreting statistical results
- Preparing clinical study reports including integrated summaries for submissions
- Utilizing your strong communication skills to present and explain the methodology and consequences of decisions.
- Understand and follow FDA regulations which affect the reporting of clinical trial data. This includes good clinical practice and guidelines for electronic submissions.
- Contribute to the creation maintenance documentation and validation of standards for programming tools outputs and macros
- Participate in the development of CRFs edit check specifications and data validation plans
- Provide review and / or author data transfer specifications for external vendor data
- Collaborate with internal and external functions (e.g. CROs software vendors clinical development partners etc.) to ensure meeting project timelines and goals
- Provide review and / or author SOPs and / or Work Instructions related to statistical programming practices
Qualifications
Here at Cytel we want our employees to succeed and we enable this success through consistent training development and support. To be successful in this position you will have :
About Us
Cytel is a Global CRO providing groundbreaking biostatistical software and services to large pharma and emerging Biotech clients globally. With our patients at the centre of all that we do we help to accelerate the development of drugs and devices that save lives and improve quality of life.
At Cytel our focus is to provide you with a comprehensive and competitive total reward package. In addition our world class employee benefits supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career both now and into the future.
Lifelancer ( ) is a talenthiring platform in Life Sciences Pharma and IT. The platform connects talent with opportunities in pharma biotech health sciences healthtech and IT domains.
For more details and to find similar roles please check out the below Lifelancer link.
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