Manager, Statistical Programming (South San Francisco, CA)

Location
South San Francisco, CA
Posted
May 23, 2022
Required Education
Bachelors Degree
Position Type
Full time

Sutro Biopharma, Inc. is looking for a talented and driven individual to join our team. The Manager, Statistical Programming should have a good working knowledge of clinical research and statistical programming skill to support drug development. The roll will be responsible for the creation and validation of statistical programming deliverables and should have the ability to work independently and as an effective and engaged team member in a fast-paced environment with minimal supervision. They will ensure that deliverables are completed on time, in high quality, and in accordance with industry standards.#Li-DNI

Responsibilities

  • Develop and validate SAS programs to produce high quality data sets, tables, figures, and listings for multiple projects within the timelines in accordance with company and regulatory requirements.
  • Independently implement complex analysis algorithms for assigned studies/projects.
  • Develops programs to assist data cleaning and safety review such as custom listings for manual review.
  • Develops programs to generate datasets and outputs for interim analysis, adhoc requests, regulatory submission, and publication.
  • Ensure the consistency of programming and outputs across studies/projects and compliance with industry standards.
  • Oversee CRO’s deliverables including but not limited to reviewing dataset specifications and validating selected datasets (SDTM, ADaM) and TFLs.
  • Review and provide feedback on CRF, data transfer agreement, SAP, Mockup shells.
  • Review/revise SOPs and Work Instructions, maintain internal documents, and contribute towards process improvement and data standardization.

Qualifications

  • Bachelor or Master’s degree in life science, computer science or equivalent relevant degree.
  • 8+ years (BS) or 6+ (MS) of SAS programming experience for Pharmaceutical/ biotech/ CRO.
  • 5+ years of experience in writing SAS macros.
  • Strong collaboration and excellent verbal and written communication skills.
  • Demonstrated proactivity and strong attention to detail.
  • Ability to manage multiple complex projects and priorities with minimal supervision.
  • Knowledge of GCP, CDASH/CDISC.
  • Excellent understanding of CDISC SDTM and ADaM standards.
  • Responsibilities may require out of “normal” work hours to meet business demands.
  • Experience in oncology is preferred.
  • Experience in managing CRO is a plus.

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 accommodations.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.

Salaries listed on jobsites may not be representative of salary ranges at Sutro Biopharma.

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.

Company Overview

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.