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Sr. Statistical Programmer

Morristown, NJ 07960

Posted: 05/02/2023 Employment Type: Contract Job Category: Data Sciences Job Number: 557384 Is job remote?: Yes Country: United States

Job Description

Pay 70-80/h depending on exp
 
 POSITION SUMMARY:
This essential team member will be responsible for supporting the statistical programming efforts for specific projects and studies, including developing, testing, maintaining, validating, and documenting SAS programs. As part of the Statistical Programming team, this person will also provide technical expertise to the development of SAS programming standards and procedures.
ESSENTIAL FUNCTIONS:
To perform this job successfully an individual must be able to perform each essential function satisfactorily.
  • Generate analysis datasets, tables, figures, and listings to support the statistical analysis of clinical trials .data in support of regulatory submissions and publications.
  • Generate SDTM domains, ADaM datasets, and Define.xml or Define.pdf files.
  • Perform quality control for SAS programs and other study documents (e.g., presentations and reports).
  • Maintain complete and auditable documentation of all programming activities.
  • Review output across SAS programs to ensure consistency.
  • Provide statistical programming support to supplemental or exploratory analyses for regulatory agencies or any other internal and external ad-hoc requests.
  • Assist in programming, testing, and documenting SAS global utility programs and tools in accordance with standards and validation procedures.
  • Participate in the development and/or maintenance of departmental procedures and standards.
  • Review CRFs, edit check specifications, and table mock-ups.
  • Works effectively with cross functional groups, study team, and vendors.
  • Participates in monitoring CRO activities and reviewing CRO deliverables as necessary.
  • May assist in creation of table, figure, or listing mockups under supervision of statisticians.
  • May train and mentor new programmers.
  • Other duties as assigned.
QUALIFICATIONS:
  • Bachelor’s degree in Statistics, Mathematics, or Computer Science or in a related field.
  • Minimum of 5 years Biotechnology/Pharmaceutical/CRO industry experience as a clinical trial SAS Programmer.
  • Knowledge of Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/SQL and SAS/ODS.
  • Demonstrates extensive knowledge with industry standards, such as the ICH guidelines, CDISC data structures, 21 CFR Part 11, and FDA guidelines.
  • Excellent organizational skills, time management, and ability to coordinate workload and meet established deadlines.
  • Excellent communication and interpersonal skills to effectively interface with others.
  • NDA submission experience is a plus

REQUIRED KNOWLEDGE AND ABILITIES:
  • Strong verbal and written communication skills are essential.
  • Excellent organization and multi-tasking skills.
  • Exceptional interpersonal skills and problem solving capabilities.
  • Proven meeting planning skills.
  • Ability to work effectively across a matrix organization.
  • Ability to work independently and prioritize with minimal daily instruction.
  • Ability to think strategically in order to improve current processes
NY and CO candidates may not be considered

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.

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