Senior Director, Statistical Programming

Summary:

Serves as the functional Head of Statistical Programming, responsible for the oversight of Statistical Programming activities for all clinical development programs as well as for assigning and overseeing the activities of other statistical programmers. Works with the Senior Vice President, Biometrics to create, implement, and modify Statistical Programming policies and procedures.  Hires and mentors qualified statistical programmers with respect to the establishment and achievement of career/professional development, project, and corporate goals.  Serves as a member of the Biometrics leadership team. 

Essential Duties and Responsibilities 

• Provide oversight of Statistical Programming activities.
• Collaborate closely with Biostatistics, Clinical Data Management, Clinical Operations, and other functions to provide programming support.
• Oversee the activities of CRO programming team to ensure adherence to scope of work and service agreements, and to ensure deliverables are met in accordance with study milestones/timelines and with quality.
• Perform programming QC/validation of SAS code for SDTM datasets, ADaM datasets and TFLs.
• Review CDISC specifications for SDTM and ADaM datasets as well as define.xml, reviewers guide documents and validation reports.
• Program TFLs for study related ad hoc analyses, posters, and presentations.
• Participate in internal study team meetings as well as teleconferences with vendors and study personnel.
• Participate in study document reviews, e.g. clinical study protocols, statistical analysis plans (SAP), Mock Tables, Figures and Listings (TFL) shells.
• Review and ensure adherence to programming budgets.
• Participate in the creation of company data and programming standards.
• Participate in the development and review of Statistical Programming SOPs.
• Mentor junior statistical programmers.
• Ensure maintenance of the Gossamer SAS server in terms of software updates, access permissions, backup, and security.

 JOB QUALIFICATIONS

• Master's degree in Biostatistics, Computer Science or a related field plus ten years of Statistical Programming experience in the pharmaceutical / CRO industry; or Bachelor's degree in in Biostatistics, Computer Science or a related field with at least 15 years of relevant industry experience
• Management of people and projects, at least 10 years of relevant industry experience
• Experience building in-house programming departments, SOP and process efficiency skillsets
• Proven experience delegating and prioritizing programming tasks
• Experience with NDA/BLA or other regulatory filing, including ISS or ISE
• Global clinical trial and CRO management experience
• Ability to multi-task and provide leadership across entire portfolio in relation to programming
• Ability to assess people skills and manage to place people in successful positions
• Strong knowledge with CDISC standards for SDTM and ADaM and Statistical Programming requirements for regulatory submissions
• Excellent SAS programming skills, including SAS/Base, SAS/STAT, SAS/GRAPH, SAS/SQL and SAS/Macro
• Strong working knowledge of FDA/EMA & ICH/GCP regulations and guidelines
• Excellent written and verbal communication skills
• Demonstrated ability to work independently to manage complex projects with multiple priorities in a fast-paced, team-based environment

Gossamer Bio is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants and complies with all applicable national, state and local laws governing nondiscrimination in employment.

For California based applicants, the expected salary range for this position is $215,000 to $245,000. Actual pay will be determined based on experience, qualifications, and other job-related factors permitted by law.  This position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. This position also qualifies for the benefits as listed below:

Gossamer Bio offers highly competitive benefit plans and programs, including medical, dental and vision insurance, 401(k) and 401(k) matching , long-term incentive plan, disability plan, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans. For additional general information on Company benefits, please visit https://www.gossamerbio.com/work-at-gossamerbio/