With oversight at a team/site/staff level, lead complex studies and submissions. Develop protocols, review case report forms (CRFs), and develop analysis plans. Provide input or write specifications for tables and analysis files. Communicate with clients regarding study protocol or statistical analysis issues as they arise. Interpret analyses and write statistical sections of study reports. Accountable for controlling costs and maximizing revenue recognition.
- Production of High-Quality Deliverables: Completes and reviews more complex assigned tasks with a focus on accuracy. Oversees team with same expectations. Prioritizes and works proactively to gain efficiency.
- Leadership: Perform as lead statistician on complex studies and for integrated summaries or eSubmissions, where applicable. Through this, works with the team to ensure high quality deliverables, delivers on time within budget, ensures compliance with Standard Operating Procedures (SOPs), ensure consistency across teams and across protocols, manages/delegates data quality issue resolutions. As a lead of groups of studies within a compound, also prioritizes and leads proactively to gain efficiencies in work across protocols. Responsible for driving statistical discussions, actively participates in internal project team meetings, provides timely progress updates. If in lead role, runs meetings, provides timeline updates, assess resource needs, and documents and follows up on actions. Supports colleagues and provides motivation.
- Datasets: Writes and maintains programming specifications, with a focus on efficacy. Manages dataset derivations and assignment. May program analysis datasets, including complex domains and derivations. Handles analysis set derivations and assignment.
- Tables, Listings and Figures (TLFs): Writes programming specifications for statistical analyses outputs. Checks outputs for format and content. Ensures consistency across items produced. May program complex Tables/Figures (Main or QC), using Bios tools where applicable.
- Timelines: Plans, documents, and negotiates timelines forecasts resource needs, identifies out of scope work.
- Customer: Serves as primary point of contact for customer. Responsible for building and maintaining effective client relationships, providing direction, support and oversight of statistical activities. Consults on operational topics with clients as well as on statistical/programming topics, regardless of complexity. Provide best in class solutions. Act as oversight on any study, regardless of complexity. May oversee programs of studies or relationships.
- Knowledge Sharing: Helps train staff regarding operational and technical items. Provides new topics and training materials at a department/site/ team/Global level. May be expected to act as subject matter expert (SME) to mentor senior staff, including offshore. Expected to mentor staff to contribute to conferences, as well as society/university involvement. May be contributing to the advertisement of IQVIA Biostatistics (e.g. meeting with clients there) and connecting with thought leaders.
- Risk Management: Identifies risks to project delivery and/or quality, leads in a way that risks are avoided. Anticipates risks to avert need for study level escalations, supports lead in implementing risk mitigation actions. Handles most study level escalations that do not impact the account relationship and escalates for support to business segment owners/client owners/managers.
- Lock and Unblinding Process: Leads the database lock and unblinding process. May participate on the biostatistics randomization team (drafts randomization specifications and/or perform quality control (QC) review of randomization schedules). Serves as unblinded lead statistician in addition to overseeing lower level Bios new to unblindings. May attend DMCs.
- Statistical Expertise: Provide expert statistical input into review of statistical deliverables (i.e. statistical section of a protocol, statistical analysis plans, table shells, programming and table specifications, data review, tables, listings, figures and statistical sections for complex and/or integrated reports). Provide expert input into data management deliverables (i.e. database design, validation checks and critical data). Perform senior biostatistician review (SBR). Produce or perform quality control review of sample size calculations for complex studies.
- Financials: Shares accountability (with resource managers) for the financial success of assigned studies. Accountable for controlling costs and maximizing revenue recognition. Also responsible for sharing budget expectations with the team. Responsible for negotiating out of scope work. Understands 'scope of work', contract, and budget assumptions. Project leads collaborate on creation/revisions of Estimate at Completion (EAC) reporting.
- Proposals: Able to review and comment on proposals/budgets at a study level. May contribute to request for proposals (RFP) as well as full service proposals. Expected to present at bid defenses and contribute to FSP bids.
- Other Responsibilities: As defined on ad-hoc basis by senior managers. May assist with cross functional collaboration.
- Bachelor's Degree Biostatistics or related field and 5 - 7 years relevant experience Req
- Master's Degree Biostatistics or related field and 5-7 years relevant experience Pref
- Typically requires 5 - 7 years of prior relevant experience, or equivalent combination of education, training and experience.
- Requires advanced knowledge of job area, and broad knowledge of a other related job areas, typically obtained through advanced education combined with experience.
- Excellent written and oral communication skills including grammatical/technical writing skills.
- Excellent attention and accuracy with details.
- In-depth knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
- Familiarity with moderately complex statistical methods that apply to applicable clinical trials.
- Strong individual initiative.
- Strong organizing skills.
- Strong working knowledge of SAS computing package.
- Familiarity with other relevant statistical computing packages such as nQuery.
- Strong commitment to quality.
- Ability to effectively manage multiple tasks and projects.
- Ability to lead and co-ordinate small teams.
- Ability to solve moderately complex problems.
- Ability to establish and maintain effective working relationships with coworkers, managers and clients.
- Expert knowledge of relevant Data Standards (such as CDISC/ADaM).
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