Senior Statistical Programmer

Join Lifelancer as a Senior Statistical Programmer!

Who Are We Looking For?

At Lifelancer, we are on the lookout for a highly skilled and experienced Senior Statistical Programmer to join our dynamic team. If you have a background in Biostatistics, Mathematics, or a related field, and possess the necessary skills and experience listed below, we want to hear from you!

Qualifications and Experience

Ideal candidates will have:

• BS or higher degree in Biostatistics, Mathematics, or related fields, or a combination of education, training, and work experience.
• 5-9 years of experience as a Statistical Programmer in CROs, pharmaceutical companies, biotech companies, or similar.
• Extensive knowledge of GCP and ICH Guidelines.
• Experience in business development activities, supporting sales teams in the preparation of proposals and bid defenses.
• Expertise in technology implementation and process automation within CROs, pharmaceutical companies, biotech companies, or similar.
• Experience in implementing quality systems.
• SAS Certified Specialist: Base Programming Using SAS.
• SAS Certified Professional: Advanced Programming Using SAS.
• Strong analytical mindset and logical thinking capabilities.
• Proficient computer skills and adaptability to different computer systems.
• Advanced SAS programming and proficiency with other statistical software.
• Excellent written and oral English communication skills.
• Ability to define problems, collect data, establish facts, and draw valid conclusions.
• Effective communication with internal and external contacts.
• Proven ability to manage multiple projects and timelines efficiently.
• Strong organizational, time management, and initiative skills.
• Excellent communication and presentation skills.
• Effective people skills and ability to work as a team player.

Your Responsibilities

As a Senior Statistical Programmer, you will:

• Collaborate with Data Managers, Statisticians, and Clinical Project Managers on ongoing clinical studies to ensure consistency and adherence to quality control procedures.
• Participate in the creation and review of key statistical documents including:
  • Case Report Forms
  • Data Specifications
  • Data Transfer Agreements
  • Statistical Analysis Plans
  • Tables, Listings, and Figures Shells
  • CDISC Mapping Documentation
• Liaise with Statisticians, Data Management, and Biostatistics Managers to discuss progress and address outstanding issues.
• Coordinate with sponsor company personnel, Central Event Adjudication Committees, Data Safety Monitoring Committees, and other third parties involved in statistical programming activities.
• Derive and adapt data for analysis, produce patient listings, summary tables, figures, and patient profiles using SAS Programming.
• Validate SDTM Domains based on provided specifications, execute Pinnacle 21, review SDTM Specifications, SDTM reviewer guides, Define.XML, and other relevant documentation.
• Validate ADaM Datasets based on provided specifications, execute Pinnacle 21, review ADaM Specifications, produce ADaM Reviewer guides, Define.XML, and other necessary documentation for ADaM derivation as part of CDISC Mapping.
• Train project team members to fully utilize company procedures and Biostatistics Reporting Environment.
• Apply company standards and actively participate in improvements for project harmonization and standardization.
• Participate in sponsor audits, regulatory authority inspections, and other third-party meetings as needed.
• Perform necessary administrative functions.
• Enter and update data in relevant CTMS modules.

If you meet these qualifications and are eager to contribute to cutting-edge projects, apply now! Visit the following link to submit your application for quicker response:

Company Name: Lifelancer

Job Title: Senior Statistical Programmer