Sr. Director, Statistical Programming

Position Overview:

Reporting to the VP of Biometrics, this role will manage the statistical programming efforts for all projects and studies, including overseeing the development, testing, maintenance, validation, and implementation of statistical programming SOPs and work instructions. This individual will also develop and maintain CDISC-compliant and submission-ready SAS programs, SDTM, ADaM, and summary tables and figures. This essential team member will oversee the statistical programming of FTEs, contractors, and CROs.

Responsibilities:

• Provide strategic direction and leadership for the statistical programming function.
• Demonstrate excellent leadership skills within the department. This includes taking an active role in departmental and company activities (e.g., management meetings), ensuring employees adhere to corporate policies, and following up with management as appropriate.
• Train and mentor new programmers, and manage contractor programmers as needed.
• Participate in formal staff review processes e.g. performance and salary reviews to corporate standards and timescales.
• Perform vendor qualifications in regards to statistical programming functions and manage CROs regarding programming issues and activities to ensure on time deliverables within budget.
• Generate, validate, and/or review tables, figures, and listings to support the statistical analysis of clinical trials data in support of regulatory submissions and publications.
• Generate, validate, and/or review SDTM domains and ADaM datasets and associated specifications.
• Generate or perform quality control for SAS programs and other study documents (e.g., presentations and reports).
• Maintain complete and auditable documentation of all programming activities.
• Manage datasets and output across SAS programs, studies, and indications to ensure consistency.
• Manage and provide statistical programming support to supplemental or exploratory analyses for pharmacovigilance, regulatory agencies, or any other internal and external ad-hoc requests.
• Develop and/or maintain departmental procedures and standards.
• Adhere to departmental and regulatory agency procedures and standards.
• Review CRFs, edit check specifications, and table, figure, and listing mock-ups.
• Manage, generate, and/or review blankCRF, define.xml, and define.pdf documents.
• Works effectively with cross-functional groups, study teams, and vendors.
• Assist in creation of table, figure, or listing mockups under the supervision of statisticians.
• Other duties as assigned.

Requirements:

Education and Experience

• Bachelor’s or Master’s degree in Statistics, Mathematics, or Computer Science or in a related field. 
• Minimum of 15 years Biotechnology/Pharmaceutical/CRO industry experience as a statistical programmer. 
• Minimum of 5 years’ experience of leading a statistical programming team required.
• Extensive knowledge of Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/SQL and SAS/ODS.
• Demonstrates extensive knowledge of industry standards, such as the ICH guidelines, CDISC standards/implementation guides, 21 CFR Part 11, and FDA guidelines.
• Thorough knowledge of the clinical development process from development, launch through life cycle management.
• NDA/BLA submission experience is a must.

Competencies and Attributes:

• Demonstrated leadership to drive results that are needed to achieve company objectives in accord with Prothena’s culture and values – courageous, imaginative, selfless and joyful
• Maintain a positive, results-orientated work environment, building partnerships and modeling teamwork, communicating to the team in an open, balanced, and objective manner.
• Excellent organizational skills, time management, and ability to coordinate workload and meet established deadlines.
• Excellent communication and interpersonal skills to effectively interface with others.
• Ability to think strategically to improve current processes.

Compensation Overview:

The anticipated annual salary range for this role is $235,000 to $325,000.  This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting.  We may ultimately pay more or less than the posted range, and the range may be modified in the future.  The final salary offered to a successful candidate will be dependent on several factors that may include – but are not limited to – the final job level offered, the type and length of experience within the job and industry, relevant education, qualifications, skills, certifications, performance, and business or organizational needs.

The hired applicant will be eligible to receive an annual bonus and an equity grant in the form of stock options.

Health & Wellness Benefits, 401(k) and PTO Overview:

• All Prothena employees (and their families) are covered by medical, dental, and vision insurance, with Prothena paying ~90% of plan premiums. 
• Prothena pays the full premium for basic life and disability insurance for all employees.  
• Prothena employees are also eligible to enroll in our Company’s 401(k) plan and are always 100% vested in their account balances.  The 401(k) plan provides for a quarterly, non-discretionary, 3% company-paid contribution on eligible earnings, as well as an additional, annual discretionary Company match of up to 2% of eligible earnings.  
• New Prothena employees are also eligible for 17 days of paid vacation accrued over the course of the first year of employment, paid sick time in accordance with state law, and company-paid holidays.