Manager, Biostatistical Programming
The Manager, Biostatistical Programming is an exciting opportunity to be a critical part of the clinical development group of a high growth organization that is dedicated to addressing the global smoking health and nicotine addiction epidemic. The Manager, Biostatistical Programming is an experienced Statistical Programmer with advanced knowledge of statistical programming methods, languages and data structures and capabilities in leading analysis and reporting activities and will be responsible for statistical programming deliverables across Achieve’s development programs. The incumbent is responsible for managing and supporting all aspects of study deliverables related to clinical and statistical programming as needed. This includes managing external data vendors, CROs (programming aspect), assisting in database lock, and creating tables/listings/figures. The Manager, Biostatistical Programming is responsible for making decisions and recommendations that impact the efficiency, timeliness and quality of deliverables and provide leadership, direction and technical and project specific guidance to cross-functional teams.
- Collaborate/oversee external vendors (CROs programming aspect)
- Creates programs using statistical analysis system (SAS) language to support the clinical area.
- Manage external data (i.e., local, and central lab data, pk data)
- Assist in Database lock – creating edit checks, reviewing data to ensure a clean database
- Recognizes data inconsistencies and initiates resolution of data problems.
- Provides expertise in the design and development of clinical trials, protocols
- Develops SAS programs to create submission datasets (i.e., SDTM, ADaM datasets) that conform to industry-accepted (i.e., CDISC, FDA) specifications.
- Create/Review Define.xml files
- Creates SAS programs to produced tables, listings, and figures (TLFs) specified in the statistical analysis plan document and associated TLF shells and for regulatory, publications or press releases.
- Develops a study-specific SAS program validation plan and create programs to verify CRO results
- Completes programming and validation tasks within project timelines.
- Provides expertise in the design and development of clinical trials, protocols, and case report forms
- Assists in preparation/review of various project documents (e.g., protocol, Data Management Plan, Statistical Analysis Plan, Data Transfer Agreements).
- Acts as a liaison between the Biometrics Department and other functional areas in Clinical Research including project teams as needed.
- Represents the company with a high level of integrity and professionalism.
- Adheres to company policies and supports management decisions and goals in a positive, professional manner.
- Performs other tasks and projects as assigned.
QUALIFICATIONS AND EDUCATION:
- Minimum of a Bachelor’s degree in science, with no less than five years of pharmaceutical industry experience.
- Experience in multiple therapeutic areas and in various phases of drug development preferred.
- SAS certification as a SAS Certified Base Programmer preferred.
- Knowledge of SDTM and ADaM standards, able to write CDSIC standard dataset specifications and follow specifications to create SDTM and ADAM datasets (as needed)
- Mastery of SAS language and procedures commonly used in clinical trial reporting including the Macro language, BASE SAS, SAS/STAT and SAS/GRAPH
KNOWLEDGE, SKILLS AND ABILITIES:
- Highly effective oral and written communication skills; good interpersonal skills
- Able to recognize need(s), find solutions and take initiative to address issues in a pro-active manner.
- Excellent time-management, organizational, problem-prevention and problem-solving skills.
- Ability to treat confidential information with discretion and make ethical and sound business decisions on situations that may involve sensitive matters.
- Proven strategic leadership style that encourages individual development as well as effective team collaboration.
- Experience working in cross-functional, global, virtual environments. Excellent interpersonal and organizational skills, with an ability to build relationships at all levels of the organization, including external vendors, as well as manage people in a multicultural environment.
- Exceptional attention to detail
- IT literacy and the ability to handle electronic data
- Teamwork and collaboration
- Professionalism and strong work ethic
About Achieve Life Sciences
At Achieve, we are committed to bringing medicines forward that contribute to a healthier world. Achieve is a specialty pharmaceutical company committed to advancing cytisinicline as a widely available treatment option to help people battling nicotine addiction.
If you enjoy working in a dynamic team environment and are passionate about making a difference, we invite you to apply. Achieve is an equal opportunity employer poised for growth. We strive to attract, develop, and retain highly qualified individuals representing the diverse communities we serve.