Principal Biostatistician - Remote

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., 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.

Our values

• We believe in applying scientific rigor to reveal the full promise inherent in data.

• We nurture intellectual curiosity and encourage everyone to approach new challenges with enthusiasm and the desire for discovery.

• We believe in collaboration and invite a diversity of perspectives, drawing on a variety of talents to create a wealth of possibilities

• We prize innovation and seek intelligent solutions using leading-edge technology., 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.

  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.

Ihre Aufgaben

Our Senior Biostatisticians perform ad-hoc 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 project-level activities.

As a Principal 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.,

• Performing data manipulation, analysis and reporting of clinical trial data, both safety and efficacy (ISS/ISE), utilizing SAS programming

• Generating and validating SDTM and ADaM datasets/analysis files, and tables, listings, and figures ( TLFs)

• Production and QC / validation programming

• Generating complex ad-hoc reports utilizing raw data

• Applying strong understanding/experience of Efficacy analysis

• Creating and reviewing submission documents and eCRTs

• Communicating with and/or responding to internal cross-functional teams and client for project specifications, status, issues or inquiries

• Performing lead duties when called upon

• Serving as team player, with a willingness to go the extra distance to get results, meet deadlines, etc.

• Being adaptable and flexible when priorities change

Ihr Profil

• Master's degree in statistics or a related discipline. Ph.D. strongly desired.

• 8+ years supporting clinical trials in the Pharmaceutical or Biotechnology industry.

• Experience working for a CRO is strongly desired.

• Experience in sample size calculation, protocol concept development, protocol development, SAP, and preparing clinical study reports including integrated summaries for submissions.

• Good SAS programming skills for QCing critical outputs, Efficacy/Safety tables, and working closely with Programmers. Knowledge of R programming is a plus.

• Solid understanding & implementation of CDISC requirements for regulatory submissions.

• Adept in ADaM specifications generation and QC of datasets

• The ability to build strong external & internal relationships and motivate a regional or global team.

• Very effective communicator: able to explain methodology and consequences of decisions in lay terms.,

• Bachelor's degree in one of the following fields Statistics, Computer Science, Mathematics, etc.

• At least 8 years of SAS programming working with clinical trial data in the Pharmaceutical & Biotech industry with a bachelor's degree or equivalent. At least 6 years of related experience with a master's degree or above.

• Study lead experience, preferably juggling multiple projects simultaneously preferred.

• Strong SAS data manipulation, analysis and reporting skills.

• Solid experience implementing the latest CDISC SDTM / ADaM standards.

• Strong QC / validation skills.

• Good ad-hoc reporting skills.

• Proficiency in Efficacy analysis.

• Familiarity with drug development life cycle and experience with the manipulation, analysis and reporting of clinical trials' data.

• Submissions experience utilizing define.xml and other submission documents.

• Experience supporting Rare diseases and Gastro Intestinal studies would be a plus.

• Excellent analytical & troubleshooting skills.

• Ability to provide quality output and deliverables, in adherence with challenging timelines.

• Ability to work effectively and successfully in a globally dispersed team environment with cross-cultural partners.