What are the responsibilities and job description for the Manager, Statistical Programming position at Arrowhead Pharmaceuticals?
Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical 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 and San Diego, CA. 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 statistical 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 statistical methods and analysis who has experience working as a statistical programmer, preferably within a CRO or a similar group. Prior management experience will be beneficial. They will initially contribute their expertise in the area of statistical programming, with a goal to develop as a lead of the statistical programming team.
Responsibilities
- Develop targeted, study-specific SDTM and ADaM dataset checks
- Perform independent QC, from raw data to ADaM, of primary and key secondary endpoints
- Create draft output shells for ad-hoc requests, prepare analysis specs and scope
- Deliver programming results for ad-hoc analysis requests
- Review outputs provided by CROs for accuracy and consistency with the analysis plan and specs
- Review and contribute to the development of study SAP
- Collaborate with data management and their programming team to ensure appropriate data collection and reporting
- Participate in study team meeting and support statistician operational activities
- Assist in efforts to identify, develop, and implement departmental standards, applications, processes and training
- Develop and manage the statistical programming team
- Develop or support standard operation procedure preparation
Requirements:
- Master's degree in biostatistics/statistics/public health or similar field
- At least 3 years' experience of statistical programming for clinical trials
- Proficiency in SAS, including complex data manipulation, basic analysis procedures, SAS/MACRO, and SAS/GRAPH
- Interest in career development as a leading role in statistical programming in pharmaceutical industry
- Excellent verbal and written communication skills
Preferred:
- Familiarity with CDISC standards, derivation of SDTM and ADaM specifications, and regulatory submission packages
- Simulations and sample size calculation
- Proficiency in R
- Familiarity with Spotfire, Tableau, and/or Power BI
- Contributing to the writing of SAPs and related study documents
- CRO experience
- Management experience
California pay range
Arrowhead provides competitive salaries and an excellent benefit package.
All applicants must have authorization to work in the US for a company.
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