Manager, Statistical Programming

Doist; Pasadena (CA); On-site; USD 145,000 - 160,000; Full time

Job summary

Arrowhead Pharmaceuticals, Inc. in Pasadena, CA seeks a Manager of Statistical Programming to lead statistical programming across clinical studies within a dynamic biometrics team.

You will review analysis plans, develop ADaM data sets, program analyses, and collaborate with Clinical Development, Regulatory, Data Management, and CROs. A Master's in Biostatistics/Statistics and 4+ years of pharma/biotech programming experience are required; SAS proficiency and familiarity with R Studio are

Qualifications

• Master’s degree in Biostatistics/Statistics.
• 4 years of relevant programming experience in pharmaceutical or biotechnology drug development.
• Proficiency in SAS and familiarity with R Studio.
• Excellent verbal and written communication skills.
• Experience interacting with CRO vendors and oversight of programming deliverables.

Responsibilities

• Review analysis plans for appropriate methodologies.
• Review clinical data as SDTM dataset.
• Develop analysis databases (ADaM).
• Program study analyses and review results.
• Conduct ad-hoc and exploratory analyses and support manuscript preparation.
• Communicate project requirements for data cleanup and capture.
• Assist in establishing standards, applications, processes and training.
• Oversee CRO/vendor programming deliverables.

Skills

SAS

R Studio

Biostatistics

Education

Master’s degree in Biostatistics/Statistics

Tools

CDISC SDTM/ADaM specifications

Job description

Arrowhead Pharmaceuticals, Inc. (Nasdaq ARWR) is a commercial stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes.

RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead’s RNAi-based therapeutics leverage this natural pathway of gene silencing. Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics.

Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates. Arrowhead’s corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need.

The Position We are seeking a Manager of Statistical Programming to join our rapidly growing biometrics team to support clinical studies across Arrowhead’s expanding portfolio.

As an internal expert in statistical programming, you will provide technical leadership and statistical programming input to closely collaborate with other functional teams at Arrowhead, including Clinical Development and Operations, Regulatory, Data Management, Medical Affairs, Program Management and others.

Responsibilities

• Review of analysis plans for appropriate methodologies;
• Review of clinical data as SDTM dataset;
• Development of analysis databases (ADaM);
• Programming of study analyses and review of study results;
• Conduct ad-hoc and exploratory statistical analysis and support manuscript preparation;
• Communicate the project requirements for cleanup and data capture to ensure the key study variables are suitable for analysis;
• Assist in efforts to identify, develop and implement departmental standards, applications, processes and training;
• Assist in identifying consultants and the selection of service providers and oversees statistical and programming deliverables by CROs or service providers.

Requirements

• Master’s degree in Biostatistics/Statistics
• 4 years of relevant programming experience in pharmaceutical or biotechnology drug development;
• Proficiency in the use of statistical software including SAS, and familiarity of the use of R studio;
• Excellent verbal and written communication skills;
• Effective in communication and team collaboration, influencing across different functional lines;
• Understanding and experience with various aspects of a clinical development life-cycle, leading up to regulatory submission and post -approval activities;
• Experience interacting with and overseeing programming services of CRO vendors;
• Knowledge of cross-functional department functions/roles within a drug development company.

Preferred

• Understanding of regulatory guidelines related to submission of datasets using CDISC, development of SDTM and ADaM specifications

California pay range $145,000 — $160,000 USD Arrowhead provides competitive salaries and an excellent benefit package.

Candidates must have current, valid authorization to work in the country where this role is located.

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