The Associate Director, Statistical Programming will oversee clinical projects and compound level activities with multiple studies and manage internal and external resources to support project related statistical programming activities. Collaborate with internal groups and external alliances for project related programming tasks to ensure successful and effective coordination and communication. Lead and participate Statistical Programming analysis data standard or process initiative. Participate in selection and supervision of contract research organizations (CROs) for data analysis for the leading project. Provide programming expertise and hands on support to clinical projects across multiple studies on all deliverables to ensure they are completed on time, in high quality, and in accordance with industry standards.
These may include but are not limited to:
- Represent the Statistical Programming team as project or compound lead, focusing on data integrity, collaboration, and on-time deliverable.
- Interact with members of cross-study teams within the lead project, statistician, and data management personnel to establish project timelines and perform statistical analyses.
- Provide leadership to statistical programming team in production of summary tables, data listings and graphs required for trial report and clinical development, and CDISC data sets for regulatory submission.
- Provide technical or hands-on support to process clinical data required for statistical analysis. Lead the development and implementation of programming standards.
- Manage project related programming activities to ensure timely delivery of tables and data listings across studies. Direct activities with overall responsibility of developing systems, planning, and staffing to ensure quality of deliverables.
- Identify functional gaps and recommend process improvements and prepare key SOPs in programming area. Oversee the creation and maintenance of statistical programming SOPs and procedures to ensure compliance with regulations and company policies.
- Master's degree in statistics, mathematics, Computer Science or equivalent with at least 12 years’ experience in pharmaceutical or bio-pharmaceutical industry
- A minimum of 2 years’ experience working with CRO
- Prior experience in participation of NDA/BLA submissions
- Demonstrated successful project management leadership, excellent interpersonal skills, and people management skills.
- Demonstrated ability to direct teams and provide coaching and feedback, including Proven expertise in SAS and involvement in the development and implementation of programming standards, processes, and systems to improve efficiency and quality.
- Excellent problem-solving, organizational, analytical and critical thinking skills including high discretion/judgment in decision making.
- Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives.
Sound exciting? Apply today and join our team!
Sutro Biopharma, Inc. requires all new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Sutro will consider requests for reasonable accommodation.
Sutro provides a competitive benefits package that includes a choice of health, dental, and vision insurance, life insurance, flexible spending accounts, 401K plan, PTO, ESPP (Employee Stock Purchase Plan) and stock options.
As an equal opportunity employer, we believe in fostering a culture that is inclusive and values diversity in background and opinions. Sutro Biopharma hires extraordinary individuals into every position in the company and is committed to the diversity of our team. Our company progresses without regard of race, ethnicity, gender, sexual orientation, religious belief, age, disability, or citizenship status. We are dedicated to creating a safe environment where our employees can grow and succeed together.
We look forward to hearing from candidates who are interested in exploring opportunities with Sutro! Our People & Culture team/hiring managers are unable to respond and do not accept solicitations from third-party agencies.
The anticipated salary range for fully qualified candidates applying for this role at Sutro Biopharma’s California based locations will be [$185,000 – $195,000] (not including bonus, equity, and benefits). The final salary offered will be dependent on several factors that include and are not limited to relevant previous experience, job responsibilities and duration of experience, the type and length of experience within the industry and education.
Sutro Biopharma, Inc., located in South San Francisco, is a clinical-stage drug discovery, development, and manufacturing company. Using precise protein engineering and rational design, Sutro is advancing next-generation oncology therapeutics.
Sutro is dedicated to transforming the lives of cancer patients by creating medicines with improved therapeutic profiles for areas of unmet need. To date, Sutro’s platform has led to cytokine-based immuno-oncology therapies, ADCs, vaccines, and bispecific antibodies directed at precedented targets in clinical indications where the current standard of care is suboptimal.
The platform allows it to accelerate discovery and development of potential first-in-class and best-in-class molecules through rapid and systematic evaluation of protein structure-activity relationships to create optimized homogeneous product candidates.
In addition to developing its own oncology pipeline, Sutro is collaborating with select pharmaceutical and biotech companies to discover and develop novel, next-generation therapeutics. As the pace of clinical development accelerates, Sutro and its partners are developing therapeutics designed to more efficiently kill tumors without harming healthy cells.