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Syneos Health
Syneos Health
Sponsor pentru viza H1BAsistență medicalăConsultanțăLogistică
Syneos Health este o organizație complet integrată de soluții biofarmaceutice, care ajută clienții să ducă terapiile de la dezvoltarea clinică până la furnizarea comercială. Echipele sale combină expertiza clinică, afacerile medicale, activitățile comerciale, tehnologia și informațiile despre piață pentru a răspunde nevoilor în schimbare din domeniul sănătății și pentru a sprijini dezvoltarea și lansarea unor tratamente importante în întreaga lume.
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Lead Statistical Programmer, SDTM, ADaM and TLF — Syneos Health, Remote India

Lead statistical programming for SDTM, ADaM, and TLF outputs at Syneos Health. Guide programming teams, validation, regulatory submissions, and CDISC compliance across life-sciences projects.

INIndiaRemoteNormă întreagăSeniorLiderLimbă Obligatorie: englezăInginer software

Descriere

  • Develop SAS or other software programs for summary tables, listings, graphs, and derived datasets based on statistical analysis plans and programming specifications.
  • Ensure programming outputs satisfy quality standards and project requirements.
  • Conduct validation programming and resolve discrepancies with programmers, biostatisticians, and project team members.
  • Apply relevant SOPs, work instructions, and regulatory guidance, including ICH requirements.
  • Maintain project documentation, testing records, verification evidence, and quality-control materials for inspection readiness.
  • Coordinate schedules and competing deadlines across multiple active projects.
  • Create specifications for datasets and outputs with varying levels of complexity.
  • Lead internal meetings, circulate information and minutes, and follow up on action items.
  • Deliver multiple programming workstreams on schedule and prepare risk-mitigation plans.
  • Serve as lead statistical programmer by directing programming staff and monitoring deliverables.
  • Review statistical analysis plans, mock shells, programming specifications, annotated CRFs, and SAS database designs.
  • Take part in sponsor meetings, project kickoffs, and bid-defense meetings.
  • Develop programming staff through training, work review, and constructive feedback.
  • Provide technical expertise in clinical drug development, industry standards, electronic submissions, CDISC, SDTM, and ADaM.
  • Review CDISC deliverables, specifications, datasets, and regulatory documents such as DEFINE.XML for compliance.
  • Participate in industry standards organizations and communicate updates to relevant teams.
  • Help improve SOPs, policies, procedures, programming tools, and macros.
  • Transfer completed deliverables.
  • Complete other assigned work-related duties.

Cerințe

  • At least 8 years of experience in clinical statistical programming.
  • Ability to lead multiple complex or global projects involving statistical programming teams.
  • Strong expertise in SDTM, ADaM, and TLF development.
  • Experience creating SDTM and ADaM specifications.
  • Experience with oncology efficacy endpoints and outputs.
  • Regulatory submission experience is preferred.
  • Experience programming in R.
  • Strong written and verbal communication skills.
  • Immediate availability is preferred.
  • Equivalent experience, skills, or education may be considered.

Beneficii

  • Opportunities for career development and progression.
  • Supportive, engaged line management.
  • Training in technical and therapeutic areas.
  • Peer-recognition programs.
  • Total rewards program.
  • Inclusive workplace culture.
  • Minimal travel may be required.

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