Senior SAS Programmer
Rockville, MD 
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Posted 13 days ago
Job Description
Description

Job Summary:

Sr. SAS Programmer provides hands on support to clinical projects conducted by Supernus Pharmaceuticals for programming clinical trial analysis deliverables with quality and timeliness following established standards and processes. This role is responsible for programming clinical trial analysis deliverables with quality and timeliness, with a hands-on and collaborative approach with other team members. This position requires high degree of independence, technical skills and ability to produce outputs.

Essential Duties & Responsibilities:

  • Review and provide input to a Statistical Analysis Plan (SAP)
  • Write SDTM and ADaM mapping specifications according to CDISC SDTM Implementation Guide (SDTM IG)
  • Write SAS programs to produce and validate SDTM and ADaM datasets
  • Produce SDTM define.xml Package including Reviewer's Guide
  • Create SAS Annotated Case Report Forms
  • Develop SAS utility macros
  • Program Tables, Figures, and Listings (TFLs) according to approved specifications
  • Prepare analysis datasets to validate vendor provided datasets and prepare ad hoc analyses when needed
  • Contribute to standards or process improvements
  • Perform other duties as assigned

Non-Essential Duties & Responsibilities:

  • N/A

Supervisory Responsibilities:

  • N/A

Knowledge and Other Qualifications:

  • Minimum Bachelor's Degree and 4+ years or Master's degree and 2 years' experience with major in Life Sciences, Computer Science, Mathematics, Statistics or a quantitative/analytical field with pharmaceutical/CRO industry experience
  • Minimum 1+ years of hands-on SDTM conversion experience preferred
  • Ability to develop SAS programs and macros to create TFL
  • Working knowledge of CDISC standards
  • Familiarity with ICH guideline and FDA other regulatory authority guidance.
  • Excellent written and oral communication skills including grammatical/technical writing skills.
  • Excellent attention and accuracy with details.
  • Familiarity with statistical methods that apply to Phase I-IV clinical trials.
  • Strong organizational skills.
  • Ability to solve moderately complex problems (identify, propose & implement solutions).
  • Ability to work in team situations.
  • Demonstrated strong individual initiative.
  • Ability to effectively manage multiple tasks and projects.
  • Ability to lead and co-ordinate the work of small teams.
  • Ability to work in a fully self-directed manner

Other Characteristics:

  • Authorized to legally work in the United States without visa sponsorship.
  • Ability to consistently exhibit Supernus Values in interactions with employees at all levels of the organization, vendors, customers and others.
  • Ability to work independently and as part of a team.
  • Ability to maintain high ethical standards of integrity and quality.
  • Capable of being innovative and dynamic in approach to work.

Physical Requirements / Work Environment

  • Sedentary work. Exerting up to 10 pounds of force occasionally and/or carrying objects. Sedentary work involves sitting most of the time.
  • The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer screen, iPad, or other electronic device; and extensive reading
  • The worker is not substantially exposed to adverse environmental conditions

Supernus Pharmaceuticals is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, age or any other characteristic protected by law.



Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)

Supernus is an EEO/AA employer. We do not discriminate in hiring on the basis of sex, gender identity, sexual orientation, race, color, religious creed, national origin, physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law.

 

Job Summary
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Education
Bachelor's Degree
Required Experience
4+ years
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