Manager, Clinical Programming

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 for clinical programming to join our growing biometrics team to support clinical studies across Arrowhead's expanding portfolio. This is an exciting opportunity for a candidate trained in SAS programming and data analysis is who has some prior experience working as a clinical or statistical programmer, preferably within a CRO or a similar group. Prior management experience is not needed. They will initially contribute their expertise in the area of data management/clinical or statistical programming, with a goal to develop as a lead within clinical programming.

Responsibilities

• Develop, and execute edit checks and patient profile software or programs for clinical trials;
• Develop and execute data listing programs used by data managers, safety surveillance, medical or clinical operations personnel;
• Collaborate with data management to ensure appropriate data collection and reporting. Participate in study team meeting and support data management activities;
• Program and deliver results on time for ad-hoc data programming requests;
• Define and help implement statistical computing environment, specifically SAS server setup and work practices;
• Support statistical programming, from raw data to ADaM, of efficacy and safety evaluation;
• Interface with CRO and perform quality audits on CRO outputs. Review outputs provided by CROs for accuracy and consistency with the programming specs
• Assist in efforts to identify, develop, and implement departmental standards, applications, processes and training; and
• Develop or support standard operation procedure preparation.

Requirements

• Bachelor's degree in life sciences or technical field;
• At least 5 years' experience of SAS programming for clinical trials;
• Working knowledge of SAS, including complex data manipulation, data presentation and output deliver systems;
• Prior experience implementing edit checks and patient profiles on active clinical trials; and
• Excellent verbal and written communication skills.

Preferred

• Familiarity with CDISC standards, derivation of SDTM and ADaM specifications;
• Data management experience;
• Proficiency in R; and
• CRO experience.

California pay range


$120,000-$140,000 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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