Job Description
JOB DESCRIPTION Who Are You? An experienced Principal Biostatistician with a passion for clinical development and analysis, adept at utilizing advanced statistical methods, you will lead one Phase I-IV clinical studies across your region. You are excited and enthusiastic, 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.
Sponsor-dedicated: 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 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 Principal Biostatisticians provide statistical and development support and influence for the associated client's trials providing expertise into processes, clinical development plans, concept sheets and protocols, as well as potentially providing oversight of work supported by other vendors. You will formulate integrated analytical approach to mine data sources, employ statistical methods, machine learning & deep learning algorithms to discover actionable insights and automate process for reducing effort and time for repeated use.
RESPONSIBILITIES As a Principal Biostatistician, your responsibilities will include: - Independently support the study team by serving as the lead biostatistician for two Phase III studies.
- Provide guidance on complex data analyses
- Serve as the operational statistician of record for the client
- Liaise with invested parties to create statistical analysis plans and other specification documents
- Review CRO provided outputs and interacts/manages CROs with oversight activities, and timelines
- Carries out hands-on work associated with clinical studies and regulatory submissions
- Attend multiple meetings per day and prioritize multiple competing tasks while understanding how tasks are interrelated
- Demonstrates problem solving ability and critical thinking
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: - Ph.D. or M.S. in biostatistics, statistics, mathematics, or related field.
- 6-8 years of experience in pharma, biotech, or a related sector
- Experience in Cardiovascular or submissions a plus
- Experience developing SOPs a plus.
- Superior SAS programming skills
- Well-versed in the clinical and regulatory requirements for global submissions
- Advanced knowledge of clinical study designs and statistical methodologies for analysis
- Excellent interpersonal, leadership, and communication skills
- Thorough knowledge of operational aspects of clinical trial conduct and overall drug development
- Strong collaborative skills and ability to work with a cross-functional team
Job Tags
Permanent employment,