Apogee Therapeutics - Associate Director, Statistical Programming
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Requirements
• 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 • 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.
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
Benefits
• A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless • Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly • Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits • We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave • Commitment to growing you professionally and providing access to resources to further your development • Apogee offers regular all team, in-person meetings to build relationships and problem solve • E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster.
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