Original listing text, shown exactly as published by the company.
Key Responsibilities
- Serve as a lead statistical programmer on one or more clinical studies
- Provide statistical programming oversight to programming vendors
- Review and validate datasets and TFLs programmed by vendors
- Work collaboratively with Biostatistics, Data Management, Clinical Operations, Regulatory, Pharmacovigilance and other functions to deliver high quality data deliverables in timely fashion
- Work with Biostatistics and other functions to develop and implement data review/reporting tools and other statistical applications as appropriate
- Participate in developing and implementing statistical programming processes and standards
- Review study documents such as SAP, DMP, CRF, annotated CRF, TFL specifications and other relevant documents and provide expert feedback from functional perspective
- Build and mentor a team of programmers to support clinical trials and pipelines
- Generate ad hoc analyses on ongoing basis
Ideal Candidate
- Master’s Degree in Statistics, Biostatistics, Mathematics, Epidemiology or related disciplines
- A minimum of 10 years’ experience in progressive and relevant clinical trial programming experience in biotech/pharma industry
- Advanced SAS programming skills and experience in other statistical software, such as R, etc.
- Experience and in-depth knowledge in CDISC including SDTM, ADaM and controlled terminologies
- Excellent organizational skills and ability to prioritize tasks
- Excellent communication and interpersonal skills
- Experience managing CROs and other data vendors
- Strong leader with a growth mindset, willing to learn from others, and dedicated to promoting a psychologically safe environment
- Ability to keep pace in a fast-moving organization
- Advanced knowledge of state-of-art statistical programming methods in clinical study setting.
- Knowledge of ICH guidelines, FDA / EMA / other regulatory authority guidance
- Experience working with in a remote virtual environment
- Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless
- Position requires up to 15% travel including mandatory in-person attendance at All Hands meetings typically held twice per year, additional travel may be required to attend key Phase 3 meetings, typically held at the Apogee San Francisco office
The anticipated salary range for candidates for this role will be $190,000-$210,000. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.
