Principal Biostatistician

Cytel Inc Dickinson , ND 58602

Posted 2 months ago

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.

Cytel's FSP group is growing and hiring well-rounded Principal Biostatisticians to provide statistical support, with a focus on ad-hoc work for clinical studies, and some publications support, across a variety of therapeutic areas.

You will participate in the development of study protocols including participation in study design discussions and sample size calculations, and review CRFs and data review guidelines.

Additionally, you will:

  • Develop statistical analysis plans (SAPs) including analysis dataset and TLG specifications

  • Perform statistical analyses

  • Interpret statistical results

  • Help prepare clinical study reports including integrated summaries for submissions

What we need from you:

  • MS or PhD in a science or industry-related discipline with five or more (8+) years working on clinical trials.

  • 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 a plus.

  • Adept in ADaM specifications, generation and QC of datasets.

  • Submissions experience strongly desired.

  • Experience working with cross-functional teams, a Study Management Team (SMT) or similar teams for different clients.

  • Effective communicator: able to explain methodology and consequences of decisions in lay terms.

  • Team player; willingness to go the extra distance to get results, meet deadlines, etc.

  • Ability to be flexible when priorities change and deal with ambiguity.

  • Simulation and protocol design experience strongly desired.

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.

#LI-KO1

icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Biostatistician

Cytel Inc

Posted 3 months ago

VIEW JOBS 7/19/2021 12:00:00 AM 2021-10-17T00:00 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 a member of our FSP group, you will be dedicated to one of our major Pharma clients, working as an extension of their staff to leverage your experience in real-world evidence area. We are looking for a person with strong SAS programming skills, as well as, solid statistics background is highly preferred. The candidate should have a good logic, good time management and work efficiently. Must also be an effective communicator and well organized. Having prior experience in Real World Data/Evidence (RWD/RWE) is very helpful - especially, having familiarity with major databases such as Optum, Humedica, and Marketscan, etc. Having some knowledge about statistics in oncology or survival analysis is preferred. CDISC knowledge is not a must-have but highly preferred experience. Programming skills are more about data manipulation and extraction from the large databases. But it also includes statistical programming such as performing common analysis, modeling, matching cohorts, and calculating incidence/prevalence, etc. It is expected that the candidate should have a good understanding of variables/terminologies in the Iarge database and familiar with HER/EMR and Claims data. Experience with specific databases helpful: Optum, Marketscan, Humedica, etc. General requirements to do RWE/RWD analysis: * Master's Degree or PhD in Biostatistics, Applied Statistics, Epidemiology or related fields * Minimum of three years of independent SAS programming * Minimum of two years working with one or more healthcare (administrative claims or EMR) databases (MarketScan, PharMetrics, Optum, Humedica, etc.) * Good knowledge of research methodology in HEOR (health economics and outcomes research) and pharmacoepidemiology * Familiarity with pharmaceutical industry Relevant stat techniques: * Proficiency in SAS statistical procedures (PHREG, GENMOD, LOGISTIC, LIFETEST AND MIXED, etc.) * Significant and independent experience of statistical modeling of time-to-event outcomes (death, AE, hospitalization, etc.) including repeated or recurrent data and competing risk models * Advanced analytics techniques such as propensity score in analyzing Real World Data 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. Cytel Inc Dickinson ND

Principal Biostatistician

Cytel Inc