[Hiring] Principal Statistical Programmer @Syneos Health

Role Description

Principal Statistical Programmer at Syneos Health® is responsible for the following:

• 8+ years of relevant clinical/SAS/Statistical programming experience.
• Prefer to have SME level review capabilities at an experienced Senior level profile.
• Develop and validate SDTM/ADaM datasets and TLFs.
• Prepare specifications and generate Define.XML, ADRG, SDRG.
• Support safety and efficacy analyses.
• Contribute to e-submissions and ensure CDISC compliance.
• Collaborate with cross-functional teams across studies, leading clinical study trials.
• Therapeutic Areas: Oncology, Neurology, or any TA.
• Proven track record of leading multiple clinical trials and demonstrating proactive project management skills, with a minimum of 1+ year lead experience.
• Excellent understanding of the clinical domain, CDISC standards, and experience across various therapeutic areas.
• Strong communication skills, problem-solving abilities, and ability to work collaboratively in cross-functional teams, in a dynamic environment.
• Clinical Phases: Phase-I, II, III, IV, except for dedicated Phase I exposure.

Qualifications

• 8+ years of relevant clinical/SAS/Statistical programming experience.
• SME level review capabilities at an experienced Senior level profile preferred.
• Proven track record of leading multiple clinical trials.
• Minimum of 1+ year lead experience.
• Excellent understanding of the clinical domain and CDISC standards.
• Experience across various therapeutic areas.
• Strong communication and problem-solving skills.

Requirements

• Develop and validate SDTM/ADaM datasets and TLFs.
• Prepare specifications and generate Define.XML, ADRG, SDRG.
• Support safety and efficacy analyses.
• Contribute to e-submissions and ensure CDISC compliance.
• Collaborate with cross-functional teams across studies.
• Experience in therapeutic areas: Oncology, Neurology, or any TA.
• Clinical Phases: Phase-I, II, III, IV, except for dedicated Phase I exposure.

Benefits

• Passionate about developing our people through career development and progression.
• Supportive and engaged line management.
• Technical and therapeutic area training.
• Peer recognition and total rewards program.
• Commitment to building an inclusive culture.
• Opportunity to shape solutions that impact lives.

Company Description

Syneos Health is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change, and accelerate progress.

Over the past 5 years, we have worked with:

• 94% of all Novel FDA Approved Drugs.
• 95% of EMA Authorized Products.
• Over 200 Studies across 73,000 Sites and 675,000+ Trial patients.