Manager Statistical Programming (m/f/x) - limited to two years

• The position holder will manage, with direction, end-to-end delivery of Statistical Programming services for assigned studies, collaborating with CROs and other vendors to ensure high quality deliverables are on time and within budget.
• The position holder will partner with internal and external stakeholders to optimize Statistical Programming technology, processes, and standards.
• The position will have a working knowledge of Statistical Programming applications and industry standards, and moderate technical skills in working with data received from CROs and other third-party vendors.

Roles & responsibilities:

• Study level statistical activities
  • Responsible, with supervision, for study activities assigned to Statistical Programming including but not exclusive to SAPs and TFL shells review from a programming perspective, contribute to develop specifications for SDTMs and ADaM datasets, contribute to develop and validate SAS programs to create SDTM and ADaM datasets and TFLs, demonstrate knowledge with XML/PDFs, Analysis Results Metadata (ARM), aCRFs and Reviewers Guides to support SDTMs and ADaMs
  • Ensure timely and accurate completion of Statistical Programming deliverables
  • Contribute, with supervision, to documents submitted to Regulatory or Pricing Authorities
  • Must comply with international regulations and maintain inspection readiness
  • Ensure inspection readiness as well as prepare potential audits linked to assigned studies

• Vendor Oversight
  • With supervision, responsible for routine oversight of vendor delivery, to ensure compliance with the protocol, external/internal standards applicable regulatory guidelines, Policies, SOPs, and other relevant guidelines
  • Participates in drafting request for proposal for CRO selection. Reviews base-line budget and time-lines. Contributes to budget management and activities across the project duration
  • Participate in meeting or teleconferences with vendors by providing advice

• Operational Excellence Innovation
  • Participate in Global Evidence Generation initiatives to improve the harmonization and efficiency of processes and/or develop and implement innovative solutions
  • Maintains current knowledge of industry best practice in Statistical Programming methodology

• Bachelor’s degree in statistics, biostatistics, mathematics, computer science or life sciences required; master’s degree in bio/statistics preferred
• At least 2 years of experience supporting drug development and/or post marketing in clinical re-search, Pharmaceutical, CRO or Medical Device setting
• Experience in oncology Therapeutic Area and/or in late phase projects is an advantage
• Competencies and Generic Skills
• Excellent English language skills
• Good understanding of GCP and GDPR principles
• Good communication skills, both oral and written, in explaining in simple terms complex concepts
• Advanced working knowledge all SAS language, procedures and options commonly used in clinical trial reporting including the Macro language, BASE SAS, SAS/STAT and SAS/GRAPH. Knowledge of SAS Enterprise Guide and/or SAS Studio is recommended but not required
• Previous experience supporting SAS macro and/or system utility development is preferred
• Solid knowledge of new advanced statistical methods using SAS
• R knowledge is highly recommended but not required
• Thorough knowledge and understanding of the principles, concepts, methods, and standards of Clinical Research.
• Fundamental negotiation and project management skills
• Ability and interest to work remotely with worldwide team members across cultures and time zones