Senior Statistical Programmer

Cytel Software Corporation

Rockville, MD Posted 8/4/2022 Full Time Information Technology

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 aSenior Statistical Programmer, you will leverage your advanced SAS programming skills and proficiency in CDISC standards (SDTM & ADaM) tosupport or lead one or more Phase I-IV clinical trials, with a focus on any of the following studies; Immunology, Oncology, Cardiovascular, Infectious Disease, Early Development,or Medical Affairs.

  • Performing data manipulation, analysis and reporting of clinical trial data, both safety and efficacy, utilizing SAS programming;
  • Applying your CDISC know-how and proficiency in Safety andEfficacyADaM, to create and validate datasets/analysis files, tables, listings, and figures ( TLF s);
  • Generating complex ad-hoc reports
  • Preparing and validating submission packages, i.e. define.xml, Reviewers Guide, Pinnacle21
  • 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

Qualifications and Experience:

  • BSc/ MSC degree or equivalent, preferably in a scientific discipline such as Statistics, Computer Science, Mathematics, etc.
  • Must have relevant industry experience
  • 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.
  • Ability to implement the latest CDISC ADaM standards (production/validation). ADaM efficacy dataset development is required.
  • Familiarity with pooled data such as in an ISS or ISE or other pooled studies dataset. Experience is preferred but not required.
  • Proficiency in SAS MACRO development
  • Strong ad-hoc reporting
  • Solid experience in Efficacy analysis
  • Experience and or familiarwith Pinnacle21
  • Submissionsexperience utilizing define.xml and other submission documents such as SDRG, ADRG
  • Experience supporting Medical Affairs, Immunology, Cardiovascular,Oncology, Infectious Disease are strongly desirable. Oncology knowledge of efficacy endpoints is also desired.
  • 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.

#CYTELNA#CYTELINT

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.

LOCATION:
Rockville, MD 20849
Apply NowApply Now
This website uses cookies for analytics and to function properly. By using our site, you agree to these terms.