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Director of Statistical Programming (Consultant)

Boston, MA 02210

Posted: 08/02/2024 Employment Type: Contract Job Category: Clinical Development and Operations Job Number: 611138 Is job remote?: No Country: United States

Job Description



Planet Pharma's biotech client is seeking a Director of Statistical Programming. In this highly visible role, you will report directly to the Vice President of Biostatistics. The Director of Statistical Programming is accountable for the strategic and operational leadership of the statistical programming department across the full portfolio of products for early through late-stage assets. The Director of Statistical Programming will lead and optimize the contribution from the team(s) by collaborating and consulting with other functions (such as research, development, medical affairs, biostatistics, and data management, etc.), exhibiting a comprehensive understanding of drug development and associated operational requirements while demonstrating modern, enterprise, global leadership skills. The candidate will lead the effort to continuously improve processes to conform to evolving industry standards and participate in the ongoing review and development of quality systems and processes, including CDISC implementation and other internal/external initiatives.  This is a hybrid working role with a three day a week in the office requirement.
Responsibilities
  • Leads statistical programming oversight of outsourced clinical trials including project management, vendor management, coordination of internal reviews, and approval of programming deliverables.
  • Participate and provide strategic guidance in study setup, initiation procedures, and review.
  • Demonstrate extensive understanding of SAS programming concepts and techniques appropriate to the pharma/biotech industry.
  • Efficiently manage CROs to meet timelines and quality deliveries. Oversee TLFs production and validation, ensuring that CROs, vendors and internal staff meet the highest quality standards per SOPs.
  • Establish optimal relationships with internal customers and colleagues and with new or existing strategic partners and vendors.
  • Contribute to the strategic decision-making process involving programming issues for early and late phase clinical trials.
  • Communicate how programming decisions impact other functional areas.
  • Write, review, or approve the data specifications for SDTM and ADaM. Create or validate SDTM, ADaM, and TLFs.
  • Track and maintain records for all assigned projects and archiving of trial/project analysis and associated documentation.
  • Work collaboratively with multiple stakeholders to manage priorities and resources; understand and perform in accordance with regulatory standards and drug development principles.
  • Responsible for the creation and accuracy of Regulatory submission data and clinical summary report package; plan, develop, test, and document SAS programs and macros for programming efficiency.
  • Develop and utilize study metrics to monitor quality, project status, activities, and budget to identify trends and provide updates for improvements on operational performance and quality metrics.
  • Develops and maintains SOPs and policies as required to maintain overall quality and consistency of Statistical Programming.
  • Ensures that all training files are up to date and complete in accordance with SOPs and ICH/GCP.
  • Ensures that vendor/consultant levels are adequate in quality and quantity to meet the forecasted workload.
  • Ensures that appropriate training programs are in place so that vendors/consultants are adequately and properly trained for their job requirements.
Requirements
  • MS with ~10+ years of industry related experience.
  • BS with ~12+ years of industry related experience.
  • At least 5 years’ management experience.
  • Experience supporting regulatory submissions.
  • Strong analytical and problem-solving skills; expert collaboration and communication skills.
  • Proficient in SAS and apply SAS programming knowledge to solve problems related to non-routine situations and experienced in interpreting statistical analysis plans and developing analysis data set specifications.
  • Familiarity with industry data standards, including CDISC, SDTM and ADaM data models.
  • Ability and interest to work cross functionally.
  • Highly independent, curious, creative, can-do attitude, and embraces continuous improvement culture.
  • Have experience in supervising and managing vendors and consultants.
  • Have ability to work independently.
  • Be a team player and work collaboratively and multifunctionally.

 

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 is an equal opportunity employer. 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 Planet Pharma, 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.