Sr. Director, Statistical Programming

As the Senior Director of Statistical Programming reporting to the Vice President of Biostatistics, you will be accountable for all Statistical Programming deliverables in adherence to company SOPs and ICH/GCP. You will also work with the Vice President, Biostatistics to create and implement Statistical Programming policies and procedures.

This role is based out of our San Francisco, CA or Cambridge, MA office and will require 10%travel. 

Your work will primarily encompass: 

• Build out the Statistical Programming group and set up SOPs and processes for operational excellence
• Collaborate with the IT team to build and maintain secure statistical computing environment and programming infrastructure
• Conduct Statistical Programming for CSR, publications, presentations, DSUR, IB, safety data review, and ad hoc analyses
• Lead the Statistical Programming activities for regulatory submissions following CDISC standards
• Collaborate with the study statistician and study team in project planning
• Review key study-related documents including but not limited to SAP, CRFs and data management plan
• Author SDTM and ADAM specifications in collaboration with the study statistician
• Effectively manage the CRO to ensure high-quality deliverables within timeline and budget 
• Validate/QC key TFLs generated by the CRO 
• Responsible for one or more studies with concurrent tasks and timelines 
• Manage one junior statistical programmer
• Other duties, as assigned

Ideal Candidate Profile  >>>  

A love of challenging, important work. We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge, experience, and attributes for this role. 

Knowledge: 

• Bachelor or Master's Degree in Statistics, Life Sciences, Computer Science or related fields
• Thorough understanding of clinical trial reporting process, as well as regulatory reporting requirements including electronic data submissions and CDISC implementation
• Thorough knowledge of SDTM/ADaM specifications and programming
• Strong SAS programming skill  
• Able to guide the successful completion of major programs and projects 
• Strong analytical and communication skills 
• Knowledge and experience in meeting regulatory guidelines, including both FDA and international regulatory agencies 
• Broad knowledge of medical/biological terminology in relevant therapeutic areas 

Experience: 

• 10+ years Statistical Programming experience in biotech/pharmaceutical industry 
• Experience in managing the Statistical Programming team
• Extensive experience of leading both early and late-phase clinical studies including programming and validation of SDTM and ADaM data sets, tables, figures, and listings
• Expert level SAS programmer with experience in delivering complex programming assignments, macros and analyses
• Experience with oncology trials is preferred
• Experience with R is a plus
• Experience with BLA or NDA/sNDA to FDA/EMA is preferred. Experience with other major global health authority submission is a plus
• Experience in management of CROs with respect to Statistical Programming
• Building and maintaining strong collaboration with key stakeholders from different disciplines across the organization

Attributes: 

• Leadership skills in proactive strategy setting, priority evaluations, adapting to changes, conflict resolution, and effective partnership 
• Statistical programming expertise and experience in managing the activities of clinical trials 
• Strong verbal and written communication skills 
• Ability to effectively represent Biostatistics Programming in multidisciplinary meetings 
• A commitment to excellence  
• Self-motivated and enthusiastic; fast learner who can identify the core project challenges and expeditiously change course as required in a fast-paced organization
• Have impeccable professional ethics, integrity and judgment

The base pay range for this position is expected to be $223,000 - $270,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits.

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