Executive / senior industry position
Share this Job
Date: May 15, 2020
Company: Cytel Inc
Join us in playing an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes!
Cytel provides unrivalled biostatistics and operations research to improve drug development success rates, crucial for human welfare. Focused on using innovative applications of statistical science and adaptive clinical trial design, Cytel is at the cutting edge of technology and human ingenuity, driving healthcare forward.
We are hiring a remote Principal Statistical Programmers to join FSP group. Position is remote in North America (US/Canada) with option to work from any of our offices in Waltham, MA, King of Prussia, PA and Seattle, WA.
As a seasoned Statistical Programmer with excellent communication and leadership skills, you will leverage your strengths in SAS programming and implementation of CDISC standards (ADaM / SDTM) to lead Phase I-IV clinical trials, performing the following;• performing data manipulation, anaysis and reporting of clinical trial data, both safety and efficacy, utilizing SAS programming• applying your CDISC know-how and proficiency in SDTM and ADaM, to create and validate datasets/analysis files, tables, listings, and figures ( TLF s)• devising data submission strategy to manage legacy data and pooling of data• Development Safety Update Reports (DSURs)• Periodic Benefit-Risk Evaluation Reports (PBRERs)• Investigators brochures (IBs)• Regulatory and/or Payer submission related analysis data sets and/or TFLs• Associated quality and process documentation as per applicable business processes• Pharmacokinetics/pharmacodynamics data preparation and analysis• Manipulating and analyzing adjudicated data• Data preparation and analysis for Global Medical Affairs work• Clinical Trial Transparency deliverables (data de-identification, results posting files)• Timely upload of documents to eTMF (Provide the complete spelling of this acronym) • generating complex ad-hoc reports• applying your strong understanding/experience with Efficacy analysis;• preparing submission packages• 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
What we are looking for:• Bachelor’s degree or equivalent, preferably in a scientific discipline such as Statistics, Computer Science, Mathematics, etc.• 10+ years of SAS programming experience in the Pharmaceutical & Biotech industry.
• 5 years of study lead experience, includes leading team of programmers. Experience leading global teams highly desired..
• Familiarity with drug development life cycle and experience with the manipulation, analysis and reporting of clinical trials’ data.• Strong SAS data manipulation, analysis and reporting skills.• Strong DSMB (Data Safety Monitoring Board) reporting experience• Strong AdaM dataset pooling for ISS/ISE• Solid experience implementing CDISC Standards (SDTM/ADaM)• Proficiency in SAS MACRO development• Strong ad-hoc reporting• Experience with Pinnacle21• CNS experience strongly desired.• Ability to work effectively and successfully in a globally dispersed team environment with cross-cultural partners.
What’s in it for you:
• You will have the opportunity to play an integral role helping our clients and the industry shape the future of drug development• You will be part of an exciting new chapter in Cytel’s history with high growth and opportunities to progress in Senior and Leadership positions within the company• Work in an environment designed for an entrepreneurial minded person with a lot of energy, ideas and courage for their implementation• Work with and leverage the best and brightest minds in the industry
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.
Nearest Major Market: New Jersey Job Segment: Statistics, Developer, Programmer, Computer Science, XML, Data, Technology