Associate Director, Statistical Programming

At Constellation we know that our success as a company lies in the hands of individual employees across every element of our company working together.  To foster this success, we strive to create a diverse, challenging, exciting, and fun work environment for all employees. We believe that each team member has the ability to impact and improve the lives of patients. We are #BrighterTogether.

The Associate Director, Statistical Programming is responsible for providing hands-on programming support, as well as technical and project leadership, ensuring the quality and timely delivery of all statistical programming deliverables for clinical studies and/or regulatory submissions.  The position may also include people management responsibilities for statistical programmers.  This position reports to Senior Director, Biostatistics.

 
How you will spend your day:

• Provide input in the design and development of case report forms and clinical study databases
• Review or author SDTM and ADaM datasets specifications for datasets programming
• Produce and deliver CDISC and regulatory compliant SDTM and ADaM standard datasets
• Write SAS programs that produce or validate tables, listings, and figures in support of clinical studies or complex integrated analyses for submission
• Provide programming support for ad hoc analysis
• Perform quality control checks/validation of SAS code and output produced by other Statistical Programmers for SDTM datasets, ADaM datasets, fit-for-purpose analysis datasets, and TLFs
• Develop global tools that increase the efficiency and capacity of the Statistical Programming group (e.g., macros or graphical user interface applications)
• Manage project timelines and programming resources with internal personnel and external vendors
• Provide oversight of statistical programming activities of vendors
• Participate in the development and review of Statistical Programming SOPs
• Train or mentor junior statistical programming staff

 
Key things about you:

• MS in Statistics, Computer Science or a related field with at least 8 years (or BS in Statistics, Computer Science or a related field with at least 10 years) of SAS programming experience in the pharmaceutical or biotech industry
• In-depth knowledge of CDISC standards for SDTM and ADaM and FDA electronic data submission requirements
• Experience in providing statistical programming support to early and late phase clinical trials and regulatory submissions (NDA, MAA)
• Experience in developing programming specifications, integrated summary safety/efficacy datasets and analysis, electronic submission data package in the eCTD format
• Prior experience of independently leading projects for regulatory submission for statistical programming activities
• Ability to manage multiple projects simultaneously, to manage conflicting priorities, and to be flexible when priorities change
• Ability to manage CRO relationships and oversee programmed deliverables
• Impeccable verbal and written communications skills
• Proactive and collaborative approach to each day
• Friendly to others and eager to work, and generally a pleasure to be around

 

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Constellation Pharmaceuticals is an Equal Opportunity Employer, a participant in E-Verify and offers a comprehensive benefits package, including health, dental, 401(k), paid vacation, tuition reimbursement, and much more.

We are not accepting unsolicited resumes from employment agencies for any employment opportunities at this time.