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Statistical Programmer

Boston, MA 02109

Posted: 06/02/2023 Employment Type: Direct Hire/Perm Job Category: Data Sciences Job Number: 562951 Pay Rate: 120,000 Is job remote?: Yes Country: United States

Job Description


We are seeking an experienced and motivated Statistical Programmer – Senior Statistical Programmer to join our rapidly growing organization. Reporting to the Statistical Programming Function Lead, the individual will be responsible for providing hands-on programming support and technical guidance, including overseeing, developing, testing, maintaining, validating, and documenting SAS programs. As part of our programming team, this individual will also need to guide and validate the CRO programming deliverables and work collaboratively with internal and external teams in results reporting and regulatory submissions.

 

Responsibilities
  • Lead study related programming activities by making sure statistical programming deliverables are delivered within timelines and with high quality.
  • Review CRO deliverables and perform acceptance checks and validation to ensure that statistical programming deliverables are accurate, complete, and compliant with CDISC standards.
  • Perform hands-on SAS programming to generate TLFs to support ad hoc requests and decision making.
  • Review data management related documents (such as CRF Specification, data transfer agreements/specifications, data management plan, annotated CRF), SDTM specification, ADaM specification, Statistical Analysis Plan, and TLF Mock shells to provide statistical programming feedback; perform other tasks as needed, including UAT of clinical databases, and edit check specifications to support our data management team.
  • Review or perform the production and validation of tables, listing and figures for clinical study reports and integrated summaries in support of regulatory submissions and publications.
  • Review or perform the production and validation of SDTM and ADaM datasets, define documents and reviewer’s guides along with Pinnacle 21.
  • Maintain complete and auditable documentation of all programming activities.
  • Adhere to departmental and regulatory agency procedures and standards.
  • Work with cross functional groups, study team, and vendors.
  • Identify, develop, and maintain statistical programming standards, processes, and SOPs.

 

Required Qualifications
  • Master’s degree in Statistics, Mathematics, Computer Science or a related field with 1-2+ years Biotech/Pharmaceutical/CRO industry experience OR Bachelor’s degree in Statistics, Mathematics, Computer Science or a related field with 3-4+ years Biotech/Pharmaceutical/CRO experience.
  • Extensive knowledge of Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/SQL and SAS/ODS.
  • Familiar with relevant industry standards, such as the ICH guidelines, CDISC standards/implementation guides, 21 CFR Part 11, and FDA guidelines.
  • CNS drug development experience is a plus.
  • Excellent organizational skills, time management, and ability to coordinate workload and meet established deadlines.
  • Excellent verbal and written skills, allowing for an open and effective dialogue throughout the company.
  • Attention to detail and quality are critical to success.
  • Highly accountable for the results and outcomes of their responsibilities and understands the impact of their efforts, results, and attitudes on others.
  • Uses teamwork to work cooperatively toward the most effective solutions, championing the best ideas of team members, and assisting where help is needed yet is capable of highly independent work when efficiency is required.
  • Results-oriented individual who is highly motivated, decisive, flexible in thought, and has the creativity to excel in and contribute to a rapidly growing company.
  • Forward thinking mindset with the ability to manage multiple projects and identify and resolve issues.

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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