Principal Biostatistician

7 days ago

India Cytel Full time

Our commitment to developing our staff is only surpassed by our commitment to advancing treatment options available to patients. At Cytel, we work hard to create successful careers with significant professional growth for our employees and as a result work hard to make Cytel successful. Cytel is a place where talent, experience, and integrity come together to advance the state of clinical development.

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 Principal 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.

As Principal Biostatistician, adapt at utilizing advanced statistical methods, you will support or lead one or more Phase I-IV clinical studies. Experience of primarily leading medium complexity clinical trials (starting from Design to Archival experience) and supporting some project-level activities.

Summary of Job Responsibilities:

• Demonstrated experience in project leadership: project planning, interaction with different stakeholders, scientific supervision of statisticians.

• Scientific leader: excellent knowledge and experience in survival analysis, and linear and generalized linear models.

• Capacity to interface effectively with clinicians and statistical programmers.

• Capacity to work independently.

• Capacity to quickly read late development protocols, understand the statistical methodology, and apply it to clinical data.

• Knowledge and practice of CDISC SDTM and ADaM data standards.

• Ability to work in compliance with the company Analysis and Reporting SOPs and project data standards.

• Able to re-in force the compliance.

• Fast learner, team-oriented, able to work independently.

• Knowledge of SAS programming SAS/STAT SAS/BASE, SAS macro language. Experience with SAS on PC and UNIX platforms.

Qualifications and Experience:

• MSc or Ph.D. in Statistics.

• 8-10 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

• Ability to read, write and speak fluently in English.

• CDISC knowledge is required.

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:

  • Master’s degree in statistics or a related discipline. Ph.D. strongly desired.
  • 9+ years supporting clinical trials in the Pharmaceutical or Biotechnology industry.
  • Ability to work independently, demonstrate initiative and flexibility through effective and innovative leadership.
  • Attention to detail and quality focused, excellent interpersonal and communication skills, innovative, and collaborative behaviours
  • SAS programming skills for QCing critical outputs, Efficacy/Safety tables, and working closely with Programmers.
  • Knowledge of R programming (R Shiny/Python)

Why Cytel?

Cytel is a Global CRO providing ground-breaking 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.

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.

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